OsteopeniaPhase 1NCT01293487

Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men.

A Phase 1 study testing RN564 in people with Osteopenia and Osteoporosis, run by Pfizer at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine the safety and tolerability of RN564 in women with osteopenia and healthy men. Read more about this study

Who is it for?: Ages 55 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Osteopenia, Osteoporosis, Bone Disease
What is being tested?: RN564
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 8 sitesUnited States
Study dates: 1 Apr 2011to 24 May 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Diagnosis of osteopenia for women (BMD T-scores between -1.0 and - 2.5 SD at the lumbar spine, the femoral neck or total hip)
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
Have at least 3 vertebral bodies in the L1-L4 region and one femoral neck site that are accessible by DXA.

Who cannot join

Evidence or history of any underlying condition, other than primary osteopenia, that affect bone metabolism (eg, hyperparathyroidism, hypoparathyroidism).
Subjects with pre-existing periodontal/dental disease or those who have undergone invasive dental procedures (eg, tooth extraction, oral surgery) within 60 days prior to Day -1.
If QTcF exceeds 455 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Ambulatory Diagnostic Center
Coral Gables, Florida, 33134
Gable Diagnostics
Coral Gables, Florida, 33134
Gables Diagnostics
Coral Gables, Florida, 33134
SeaView Research, Inc.
Miami, Florida, 33126
SeaView Research, Inc.
Miami, Florida, 33134
Miami Research Associates
Miami, Florida, 33143
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
MRA Clinical Research
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A PHASE 1 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ESCALATING DOSES OF RN564 IN WOMEN WITH OSTEOPENIA AND IN HEALTHY MEN

The purpose of this study is to determine the safety and tolerability of RN564 in women with osteopenia and healthy men.

Conditions: Osteopenia, Osteoporosis, Bone Disease
Being tested: RN564
Keywords: Phase 1, Osteopenia, RN564
Medical subject headings: Bone Diseases, Metabolic, Osteoporosis, Bone Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RN564Biological
Intravenous, single dose with experimental dose

Study groups in NCT01293487
Study group	Role	What they receive
Arm 1	Experimental	Not described Receives: Biological: RN564

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs)
Dose-limiting or intolerable treatment related AEs was defined as any of the following criteria occurred in 2 or more participants: Serious adverse events, Increased liver transaminases, Increased bilirubin (in absence of ALT/AST elevations, allergic / hypersensitivity reactions, vasculitis, Musculoskeletal pain, Increased serum creatinine, Diarrhea, enteritis or nausea, Prolongation of QTcF interval or any other criteria If considered appropriate by the Medical Monitor and Investigator. A dose level was also be considered intolerable if, in the judgment of the Investigator and Sponsor, the type, frequency, or severity of AEs becomes unacceptable.
Measured: Day 1 to Day 85
Percentage of Participants With All-Causality AEs by Grade
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.
Measured: Day 1 to Day 85
Percentage of Participants With Treatment-Related AEs by Grade
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Relatedness to drug was assessed by investigator.
Measured: Day 1 to Day 85
Number of Participants With Any Laboratory Abnormality
Criteria for abnormality: hematology: hemoglobin, hematocrit, red blood cell count: less than(<) 0.8*lower limit of normal (LLN); platelets: <0.5*LLN,>1.75*ULN, white blood cell count: <0.6*LLN, >1.5*ULN; lymphocytes, total neutrophils: <0.8*LLN, >1.2*ULN; eosinophils, basophils, monocytes: >1.2*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: >1.1*ULN; liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function: blood urea nitrogen, creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium>1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN), urine casts, granular casts, hyaline casts>1 LPF; hormones: T4, T3, TSH<0.8*LLN.
Measured: Day 1 to 85
Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation
Median change from baseline in platelets, WBC count, lymphocytes (absolute [Abs]), total neutrophils (Abs), basophils (Abs), eosinophils (Abs), and monocytes (Abs)
Measured: Baseline, last observation (up to Day 85)
Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation
Measured: Baseline, last observation (up to Day 85)
Median Change From Baseline in Hematocrit at Last Observation
Measured: Baseline, last observation (up to Day 85)
Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation
Measured: Baseline, last observation (up to Day 85)
Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation
Includes median changes from baseline in total bilirubin, direct bilirubin, indirect bilirubin, blood urea nitrogen (BUN), creatinine, uric acid, calcium, magnesium, and glucose
Measured: Baseline, last observation (up to Day 85)
Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation
Measured: Baseline, last observation (up to Day 85)
Median Change From Baseline in Liver Function Tests at Last Observation
Includes median changes in aspartate aminotransferase (AST), alanine aminotransferase (AST), gamma glutamyltransferase (GGT), and alkaline phosphatase
Measured: Baseline, last observation (up to Day 85)
Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation
Measured: Baseline, Last observation (up to Day 85)
Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation
Measured: Baseline, Last Observation (up to Day 85)
Median Change From Baseline in Free Triiodothyronine (T3) and Free Thyroxine (T4) at Last Observation
Measured: Baseline, last observation (up to Day 85)
Median Change From Baseline in T4 at Last Observation
Measured: Baseline, last observation (up to Day 85)
Median Change From Baseline in Urine WBC at Last Observation
Measured: Baseline, last observation (up to Day 85)
Median Change From Baseline in Urine pH at Last Observation
Measured: Baseline, last observation (up to Day 85)
Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure
Participants with maximum changes from baseline (defined as increases or decreases of greater than or equal to [≥]20 mmHg or ≥30 mmHg) in either standing or supine systolic blood pressure (SBP) or diastolic blood pressure (DBP) measured in millimeters mercury (mmHg).
Measured: Day 1 up to 85
Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
Participants with maximum changes from baseline (BSL) defined as: ≥25 to 50 percent (%) increase in maximum PR interval or QRS complex; increase from BSL of ≥30 milliseconds (msec) but <60 msec in corrected QT (QTc) interval or QTcF interval (QTc interval corrected using Fridericia's correction); or increase from BSL ≥60 msec in either QTc interval or QTcF interval.
Measured: Day 1 up to 85
Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit
Measured: Days -1, 8, 15, 29, 43, 57, and 85

Secondary outcomes (19)

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Maximum Observed Serum Concentration (Cmax)
Measured: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Time to Reach Maximum Observed Serum Concentration (Tmax)
Measured: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Volume of Distribution at Steady State (Vss)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Measured: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Clearance (CL)
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Terminal Elimination Half-Life (t1/2)
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)]
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf).
Measured: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Apparent Volume of Distribution (Vz/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. Based on internal clinical pharmacology guidance on the most appropriate parameter calculations for this study design, data for Vz/F was not collected instead Vss was reported.
Measured: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Percentage Change From Baseline in Total Dickkopf-1 (DKK-1) Concentrations Over Time
Measured: Day -1, Day 1 (predose and at end of infusion) and at 2, 4, 8, and 12 hours postdose, and Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57, and 85
Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time
Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082
Measured: Baseline (Days -1, 1), Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85
Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time
Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082
Measured: Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85
Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time
Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082
Measured: Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85
Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time
Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082
Measured: Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85
Mean Percentage Change From Baseline in Serum Osteocalcin Over Time
Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082
Measured: Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85
Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85
Measured: Days -1 and 85
Femoral Neck BMD at Day 85
BMD was evaluated by dual energy X-ray absorptiometry (DXA).
Measured: Day 85
Femoral Neck T-Score at Day 85
BMD was evaluated by DXA. T-score was calculated based on actual measured bone density value and is the standardized scores that reflect the standard deviations (SDs) above/below the mean. A BMD T-score of -1.0 or more indicates normal bone density. T-score between -1.0 and -2.5 indicates low bone density known as osteopenia. A T-score of -2.5 or less is diagnostic of osteoporosis.
Measured: Day 85
Mean Percentage Change From Baseline in Distal Radius BMD at Day 85
BMD was evaluated by DXA.
Measured: Baseline (Day -1), Day 85
PK/PD Model Describing the Relationship Between PF-04840082 PK Parameter Estimates/Concentrations and Changes in PD Endpoints
Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Measured: Day 1 to Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201124 May 2012

First posted10 Feb 2011 (estimated)
Study start1 Apr 2011
Primary completion24 May 2012
Study completion24 May 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteopeniaStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01293487
Sponsor's protocol ID: B1151001
Status last verified: Jun 2024
First submitted: 9 Feb 2011
Last updated: 24 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ESCALATING DOSES OF RN564 IN WOMEN WITH OSTEOPENIA AND IN HEALTHY MEN
ClinicalTrials.gov ID: NCT01293487
Acronym / sponsor ID: B1151001
Conditions: Osteopenia, Osteoporosis, Bone Disease
Keywords: Phase 1, Osteopenia, RN564
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 1 Apr 2011 (actual)
Primary completion: 24 May 2012 (actual)
Study completion: 24 May 2012 (actual)
First posted: 10 Feb 2011 (estimated)
Results: Posted 24 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the safety and tolerability of RN564 in women with osteopenia and healthy men.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 1

Arm	Type	Receives
Arm 1	Experimental	Biological: RN564

Who may qualify

Ages: 55 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of osteopenia for women (BMD T-scores between -1.0 and - 2.5 SD at the lumbar spine, the femoral neck or total hip)
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
Have at least 3 vertebral bodies in the L1-L4 region and one femoral neck site that are accessible by DXA.

Key exclusion criteria (3 listed)

Evidence or history of any underlying condition, other than primary osteopenia, that affect bone metabolism (eg, hyperparathyroidism, hypoparathyroidism).
Subjects with pre-existing periodontal/dental disease or those who have undergone invasive dental procedures (eg, tooth extraction, oral surgery) within 60 days prior to Day -1.
If QTcF exceeds 455 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RN564Intravenous, single dose with experimental dose	Biological	Arm 1

Primary outcome

Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs)
Time frame: Day 1 to Day 85
Dose-limiting or intolerable treatment related AEs was defined as any of the following criteria occurred in 2 or more participants: Serious adverse events, Increased liver transaminases, Increased bilirubin (in absence of ALT/AST elevations, allergic / hypersensitivity reactions, vasculitis, Musculoskeletal pain, Increased serum creatinine, Diarrhea, enteritis or nausea, Prolongation of QTcF interval or any other criteria If considered appropriate by the Medical Monitor and Investigator. A dose level was also be considered intolerable if, in the judgment of the Investigator and Sponsor, the type, frequency, or severity of AEs becomes unacceptable.
Percentage of Participants With All-Causality AEs by Grade
Time frame: Day 1 to Day 85
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.
Percentage of Participants With Treatment-Related AEs by Grade
Time frame: Day 1 to Day 85
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Relatedness to drug was assessed by investigator.
Number of Participants With Any Laboratory Abnormality
Time frame: Day 1 to 85
Criteria for abnormality: hematology: hemoglobin, hematocrit, red blood cell count: less than(<) 0.8*lower limit of normal (LLN); platelets: <0.5*LLN,>1.75*ULN, white blood cell count: <0.6*LLN, >1.5*ULN; lymphocytes, total neutrophils: <0.8*LLN, >1.2*ULN; eosinophils, basophils, monocytes: >1.2*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: >1.1*ULN; liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function: blood urea nitrogen, creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium>1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN), urine casts, granular casts, hyaline casts>1 LPF; hormones: T4, T3, TSH<0.8*LLN.
Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Median change from baseline in platelets, WBC count, lymphocytes (absolute [Abs]), total neutrophils (Abs), basophils (Abs), eosinophils (Abs), and monocytes (Abs)
Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Median Change From Baseline in Hematocrit at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Includes median changes from baseline in total bilirubin, direct bilirubin, indirect bilirubin, blood urea nitrogen (BUN), creatinine, uric acid, calcium, magnesium, and glucose
Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Median Change From Baseline in Liver Function Tests at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Includes median changes in aspartate aminotransferase (AST), alanine aminotransferase (AST), gamma glutamyltransferase (GGT), and alkaline phosphatase
Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation
Time frame: Baseline, Last observation (up to Day 85)
Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation
Time frame: Baseline, Last Observation (up to Day 85)
Median Change From Baseline in Free Triiodothyronine (T3) and Free Thyroxine (T4) at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Median Change From Baseline in T4 at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Median Change From Baseline in Urine WBC at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Median Change From Baseline in Urine pH at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure
Time frame: Day 1 up to 85
Participants with maximum changes from baseline (defined as increases or decreases of greater than or equal to [≥]20 mmHg or ≥30 mmHg) in either standing or supine systolic blood pressure (SBP) or diastolic blood pressure (DBP) measured in millimeters mercury (mmHg).
Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
Time frame: Day 1 up to 85
Participants with maximum changes from baseline (BSL) defined as: ≥25 to 50 percent (%) increase in maximum PR interval or QRS complex; increase from BSL of ≥30 milliseconds (msec) but <60 msec in corrected QT (QTc) interval or QTcF interval (QTc interval corrected using Fridericia's correction); or increase from BSL ≥60 msec in either QTc interval or QTcF interval.
Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit
Time frame: Days -1, 8, 15, 29, 43, 57, and 85

19 secondary outcomes

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Maximum Observed Serum Concentration (Cmax)
Time frame: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Time to Reach Maximum Observed Serum Concentration (Tmax)
Time frame: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Volume of Distribution at Steady State (Vss)
Time frame: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Clearance (CL)
Time frame: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Terminal Elimination Half-Life (t1/2)
Time frame: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)]
Time frame: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Apparent Volume of Distribution (Vz/F)
Time frame: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Percentage Change From Baseline in Total Dickkopf-1 (DKK-1) Concentrations Over Time
Time frame: Day -1, Day 1 (predose and at end of infusion) and at 2, 4, 8, and 12 hours postdose, and Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57, and 85
Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time
Time frame: Baseline (Days -1, 1), Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85
Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time
Time frame: Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85
Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time
Time frame: Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85
Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time
Time frame: Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85
Mean Percentage Change From Baseline in Serum Osteocalcin Over Time
Time frame: Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85
Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85
Time frame: Days -1 and 85
Femoral Neck BMD at Day 85
Time frame: Day 85
Femoral Neck T-Score at Day 85
Time frame: Day 85
Mean Percentage Change From Baseline in Distal Radius BMD at Day 85
Time frame: Baseline (Day -1), Day 85
PK/PD Model Describing the Relationship Between PF-04840082 PK Parameter Estimates/Concentrations and Changes in PD Endpoints
Time frame: Day 1 to Day 85

Results and safety

Results posted to the registry on 24 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF-04840082 0.3 mg/kg	6	6
PF-04840082 1.0 mg/kg	6	6
PF-04840082 6.0 mg/kg	6	6
PF-04840082 24.0 mg/kg	6	5
PF-04840082 3.0 mg/kg	8	8
PF-04840082 12.0 mg/kg	8	8
PF-04840082 18.0 mg/kg	8	8
Placebo	20	18

Primary outcome: Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs)

Time frame: Day 1 to Day 85. Count of participants. Unit: Participants

Measure	PF-04840082 0.3 mg/kg n = 6	PF-04840082 1.0 mg/kg n = 6	PF-04840082 6.0 mg/kg n = 6	PF-04840082 24.0 mg/kg n = 6	PF-04840082 3.0 mg/kg n = 8	PF-04840082 12.0 mg/kg n = 8	PF-04840082 18.0 mg/kg n = 8	Placebo n = 20
Value	0	0	0	0	0	0	0	0

Population analysed: Safety Analysis Set: All participants who received at least 1 dose of study medication.

Primary outcome: Percentage of Participants With All-Causality AEs by Grade

Time frame: Day 1 to Day 85. Number. Unit: percentage of participants

Measure	PF-04840082 0.3 mg/kg n = 6	PF-04840082 1.0 mg/kg n = 6	PF-04840082 6.0 mg/kg n = 6	PF-04840082 24.0 mg/kg n = 6	PF-04840082 3.0 mg/kg n = 8	PF-04840082 12.0 mg/kg n = 8	PF-04840082 18.0 mg/kg n = 8	Placebo n = 20
Grade 1	100.0	50.0	100.0	66.7	62.5	37.5	62.5	60.0
Grade 2	0	16.7	0	16.7	0	25.0	12.5	10.0
Grade 3	0	0	0	0	0	12.5	0	0
Grade 4	0	0	0	0	0	0	0	0
Grade 5	0	0	0	0	0	0	0	0
Missing/Unknown	0	0	0	0	0	0	0	0

Population analysed: Safety Analysis Set: All participants who received at least 1 dose of study medication.

Primary outcome: Percentage of Participants With Treatment-Related AEs by Grade

Time frame: Day 1 to Day 85. Number. Unit: percentage of participants

Measure	PF-04840082 0.3 mg/kg n = 6	PF-04840082 1.0 mg/kg n = 6	PF-04840082 6.0 mg/kg n = 6	PF-04840082 24.0 mg/kg n = 6	PF-04840082 3.0 mg/kg n = 8	PF-04840082 12.0 mg/kg n = 8	PF-04840082 18.0 mg/kg n = 8	Placebo n = 20
Grade 1	50.0	16.7	50.0	33.3	50.0	0	37.5	20.0
Grade 2	0	16.7	0	0	0	12.5	0	0
Grade 3	0	0	0	0	0	0	0	0
Grade 4	0	0	0	0	0	0	0	0
Grade 5	0	0	0	0	0	0	0	0
Missing/Unknown	0	0	0	0	0	0	0	0

Population analysed: Safety Analysis Set: All participants who received at least 1 dose of study medication.

Primary outcome: Number of Participants With Any Laboratory Abnormality

Time frame: Day 1 to 85. Count of participants. Unit: Participants

Measure	PF-04840082 0.3 mg/kg n = 6	PF-04840082 1.0 mg/kg n = 6	PF-04840082 6.0 mg/kg n = 6	PF-04840082 24.0 mg/kg n = 6	PF-04840082 3.0 mg/kg n = 8	PF-04840082 12.0 mg/kg n = 8	PF-04840082 18.0 mg/kg n = 8	Placebo n = 20
Value	3	3	4	1	3	4	4	12

Population analysed: Safety Analysis Set: All participants who received at least 1 dose of study medication.

19 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-04840082 0.3 mg/kg	0 of 6 (0%)	6 of 6 (100%)	Not reported
PF-04840082 1.0 mg/kg	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
PF-04840082 6.0 mg/kg	0 of 6 (0%)	6 of 6 (100%)	Not reported
PF-04840082 24.0 mg/kg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
PF-04840082 3.0 mg/kg	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
PF-04840082 12.0 mg/kg	1 of 8 (12.5%)	6 of 8 (75%)	Not reported
PF-04840082 18.0 mg/kg	0 of 8 (0%)	6 of 8 (75%)	Not reported
Placebo	1 of 20 (5%)	14 of 20 (70%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RN564 in people with Osteopenia and Osteoporosis, run by Pfizer at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs) (time frame: Day 1 to Day 85). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01293487.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.