Post Menopausal OsteoporosisPhase 2NCT01674621
Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
A Phase 2 study testing Abaloparatide Transdermal (50 mcg), Abaloparatide Transdermal (100 mcg) and Abaloparatide Transdermal (150 mcg) in people with Post Menopausal Osteoporosis, run by Radius Health, Inc. at 9 sites in 4 countries.
Trial summary
To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when compared to transdermal placebo and abaloparatide injection for 6 months of treatment. Read more about this study
- Who is it for?
- Ages Up to 85 years, women only
- Conditions the study is for
- Post Menopausal Osteoporosis
- What is being tested?
- Abaloparatide Transdermal (50 mcg), Abaloparatide Transdermal (100 mcg) and Abaloparatide Transdermal (150 mcg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 25 Sep 2012to 2 Aug 2013
- Phase
- Phase 2
- 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 Up to 85 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal woman, less than 85 years old.
- BMD T-score ≤-2.5 of spine or hip (femoral neck) or ≤-2.0 with previous fracture (within 5 years).
- Normal physical exam, vital signs, electrocardiogram (ECG), and medical history.
- Laboratory tests within the normal range, including serum calcium, Vitamin D, parathyroid hormone (PTH) (1-84), serum phosphorus, and alkaline phosphatase.
Who cannot join
- BMD T-score ≤-5.0 at the lumbar spine or hip.
- History of bone disorders (for example, Paget's disease) other than postmenopausal osteoporosis.
- Significantly impaired renal function.
- History of any cancer.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
United States3 sites
Study site
Atlanta, Georgia, 30319
Study site
Bethesda, Maryland, 20817
Study site
Lakewood, Colorado, 80227
Denmark3 sites
Study site
Aalborg
Study site
Ballerup Municipality
Study site
Vejle
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of BA058 Administered Via a Coated Transdermal Microarray Delivery System (BA058 Transdermal) in Healthy Postmenopausal Women With Osteoporosis
To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when compared to transdermal placebo and abaloparatide injection for 6 months of treatment.
- Conditions
- Post Menopausal Osteoporosis
- Being tested
- Abaloparatide Transdermal (50 mcg), Abaloparatide Transdermal (100 mcg), Abaloparatide Transdermal (150 mcg), Abaloparatide Injection (80 mcg), Abaloparatide Placebo
- Keywords
- BA058, Abaloparatide-SC, abaloparatide, Abaloparatide-TD, Osteo, Osteoporosis, Transdermal, Patch
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abaloparatide Transdermal (50 mcg)Drug
Also called BA058 Transdermal (50 mcg)
Abaloparatide Transdermal Microneedle Active Patch
Abaloparatide Transdermal (100 mcg)Drug
Also called BA058 Transdermal (100 mcg)
Abaloparatide Transdermal Microneedle Active Patch
Abaloparatide Transdermal (150 mcg)Drug
Also called BA058 Transdermal (150 mcg)
Abaloparatide Transdermal Microneedle Active Patch
Abaloparatide Injection (80 mcg)Drug
Also called BA058 Injection (80 mcg)
Abaloparatide Subcutaneous Injection
Abaloparatide PlaceboDrug
Also called BA058 Placebo
Abaloparatide Transdermal Microneedle Placebo Patch
| Study group | Role | What they receive |
|---|---|---|
| Abaloparatide Transdermal (50 mcg) | Experimental | Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months Receives: Drug: Abaloparatide Transdermal (50 mcg) |
| Abaloparatide Transdermal (100 mcg) | Experimental | Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months Receives: Drug: Abaloparatide Transdermal (100 mcg) |
| Abaloparatide Transdermal (150 mcg) | Experimental | Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months Receives: Drug: Abaloparatide Transdermal (150 mcg) |
| Abaloparatide Injection (80 mcg) | Active comparator | Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months Receives: Drug: Abaloparatide Injection (80 mcg) |
| Abaloparatide Transdermal Placebo (0 mcg) | Placebo comparator | Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months Receives: Drug: Abaloparatide Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months
Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine.
Measured: Baseline, 6 Months
Secondary outcomes (13)
Percent Change From Baseline in BMD of Total Hip at 6 Months
Percent change in BMD as specified by DXA scans of the total hip.
Measured: Baseline, 6 Months
Percent Change From Baseline in BMD of Forearm at 6 Months
Percent change in BMD as specified by DXA scans of the forearm.
Measured: Baseline, 6 Months
Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months
Measured: Baseline, 6 Months
Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months
Measured: Baseline, 6 Months
Percent Change From Baseline in Serum Osteocalcin at 6 Months
Measured: Baseline, 6 Months
Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months
Measured: Baseline, 6 Months
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months
Measured: Baseline, 6 Months
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
A full physical examination included, at a minimum: general appearance, skin, head/ears/eyes/nose/throat, lungs/chest, breasts, heart, abdomen, lymph nodes, musculoskeletal, extremities, and neurologic. Physical examination results that were considered abnormal were determined by the Investigator. A summary of other non-serious adverse events (AEs) and all serious AEs (SAEs), regardless of causality is located in Reported AE section.
Measured: Baseline up to 6 Months
Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes
Vital sign parameters included respiration rate (breaths/minute), body temperature (°C), systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg), and heart rate (bpm). Number of participants for each TEAE is presented. The same participant may be included in more than one TEAE category. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Baseline up to 7 Months
Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result
The following ECG parameters were recorded: rhythm, heart rate, PR interval, QRS duration and QT/QTc. ECG results that were considered clinically meaningful were to be determined by the Investigator. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Baseline up to 7 Months
Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4
Hematology laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: white blood cell (Grade 3: 1.0-1.9*10^9/liter [L]; Grade 4 <1.0*10^9/L), platelets (Grade 3: 25.0-49.9*10^9/L; Grade 4: <25.0*10^9/L), haemoglobin (Grade 3: 65.0-79.0 grams [g]/L or 4.0-4.9 mmol/L; Grade 4: <65.0 g/L or <4.0 millimole [mmol]/L), granulocytes/bands (Grade 3: 0.5-0.9*10^9/L; Grade 4: <0.5*10^9/L), lymphocytes (Grade 3: 0.5-0.9*10^9/L; Grade 4: <0.5 *10^9/L), haemorrhage (Grade 3: gross, 3 - 4 units transfusion per episode; Grade 4: massive, > 4 units transfusion per episode). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Baseline up to 6 Months
Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
Chemistry laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: sodium, potassium, chloride, inorganic phosphorus, albumin, total protein (Grade 3: 4 (+), >1.0 g%, or >10 g/L; Grade 4: nephrotic syndrome), glucose, blood urea nitrogen (BUN), creatinine (Grade 3: 3.1-6.0*normal; Grade 4: >6.0*normal), uric acid, aspartate aminotransferase (AST) (Grade 3: 5.1-20.0 units [U]/L*normal, Grade 4: >20.0 U/L*normal), alanine aminotransferase (ALT) (Grade 3: 5.1-20.0 U/L*normal; Grade 4: >20.0 U/L*normal), gamma-glutamyltranspeptidase (GGT), creatine phosphokinase (CPK), alkaline phosphatase (Grade 3: 5.1-20.0 U/L*normal; Grade 4: >20.0 U/L*normal), total bilirubin (Grade 3: 1.5-3.0*normal; Grade 4: >3.0*normal), lactate dehydrogenase (LDH), cholesterol, triglycerides, total calcium. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Baseline up to 6 Months
Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
Coagulation laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: prothrombin time (quick) (Grade 3: 1.51%-2.00%*normal, Grade 4: >2.00%*normal), partial thromboplastin time (Grade 3: 2.34-3.00 seconds [sec], Grade 4: >3.00 secs*normal). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Baseline up to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study start25 Sep 2012
- Primary completion2 Aug 2013
- Study completion2 Aug 2013
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 Post Menopausal OsteoporosisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radius Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nordic Bioscience A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674621
- Sponsor's protocol ID
- BA058-05-007
- Other IDs
- 2012-001921-29
- Status last verified
- May 2020
- First submitted
- 24 Aug 2012
- Last updated
- 16 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of BA058 Administered Via a Coated Transdermal Microarray Delivery System (BA058 Transdermal) in Healthy Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT01674621
- Acronym / sponsor ID
- BA058-05-007
- Conditions
- Post Menopausal Osteoporosis
- Keywords
- BA058, Abaloparatide-SC, abaloparatide, Abaloparatide-TD, Osteo, Osteoporosis, Transdermal, Patch
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Radius Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nordic Bioscience A/S
- Study start
- 25 Sep 2012 (actual)
- Primary completion
- 2 Aug 2013 (actual)
- Study completion
- 2 Aug 2013 (actual)
- First posted
- 29 Aug 2012 (estimated)
- Results
- Posted 19 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when compared to transdermal placebo and abaloparatide injection for 6 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Abaloparatide Transdermal (50 mcg) | Experimental | Drug: Abaloparatide Transdermal (50 mcg)Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months |
| Abaloparatide Transdermal (100 mcg) | Experimental | Drug: Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months |
| Abaloparatide Transdermal (150 mcg) | Experimental | Drug: Abaloparatide Transdermal (150 mcg)Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months |
| Abaloparatide Injection (80 mcg) | Active comparator | Drug: Abaloparatide Injection (80 mcg)Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months |
| Abaloparatide Transdermal Placebo (0 mcg) | Placebo comparator | Drug: Abaloparatide PlaceboAbaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months |
Who may qualify
- Ages
- Up to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal woman, less than 85 years old.
- BMD T-score ≤-2.5 of spine or hip (femoral neck) or ≤-2.0 with previous fracture (within 5 years).
- Normal physical exam, vital signs, electrocardiogram (ECG), and medical history.
- Laboratory tests within the normal range, including serum calcium, Vitamin D, parathyroid hormone (PTH) (1-84), serum phosphorus, and alkaline phosphatase.
Key exclusion criteria (4 listed)
- BMD T-score ≤-5.0 at the lumbar spine or hip.
- History of bone disorders (for example, Paget's disease) other than postmenopausal osteoporosis.
- Significantly impaired renal function.
- History of any cancer.
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 |
|---|---|---|
| Abaloparatide Transdermal (50 mcg)Also: BA058 Transdermal (50 mcg)Abaloparatide Transdermal Microneedle Active Patch | Drug | Abaloparatide Transdermal (50 mcg) |
| Abaloparatide Transdermal (100 mcg)Also: BA058 Transdermal (100 mcg)Abaloparatide Transdermal Microneedle Active Patch | Drug | Abaloparatide Transdermal (100 mcg) |
| Abaloparatide Transdermal (150 mcg)Also: BA058 Transdermal (150 mcg)Abaloparatide Transdermal Microneedle Active Patch | Drug | Abaloparatide Transdermal (150 mcg) |
| Abaloparatide Injection (80 mcg)Also: BA058 Injection (80 mcg)Abaloparatide Subcutaneous Injection | Drug | Abaloparatide Injection (80 mcg) |
| Abaloparatide PlaceboAlso: BA058 PlaceboAbaloparatide Transdermal Microneedle Placebo Patch | Drug | Abaloparatide Transdermal Placebo (0 mcg) |
Primary outcome
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months
Time frame: Baseline, 6 Months
Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine.
13 secondary outcomes
Percent Change From Baseline in BMD of Total Hip at 6 Months
Time frame: Baseline, 6 Months
Percent Change From Baseline in BMD of Forearm at 6 Months
Time frame: Baseline, 6 Months
Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months
Time frame: Baseline, 6 Months
Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months
Time frame: Baseline, 6 Months
Percent Change From Baseline in Serum Osteocalcin at 6 Months
Time frame: Baseline, 6 Months
Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months
Time frame: Baseline, 6 Months
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months
Time frame: Baseline, 6 Months
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Time frame: Baseline up to 6 Months
Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes
Time frame: Baseline up to 7 Months
Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result
Time frame: Baseline up to 7 Months
Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4
Time frame: Baseline up to 6 Months
Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
Time frame: Baseline up to 6 Months
Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
Time frame: Baseline up to 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Post Menopausal Osteoporosis
Recruiting
Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis
Post Menopausal Osteoporosis
RecruitingPhase 4
The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation
Postmenopausal Osteoporosis, Postmenopausal Osteopenia
Not yet recruitingPhase 4
Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMD
Osteoporosis in Post-menopausal Women
RecruitingObservational study
Sequential Therapies After Osteoanabolic Treatment
Osteoporosis, Postmenopausal
Not yet recruitingObservational study
A Retrospective and Prospective Clinical Registry for Data Collection of Perimenopausal, Menopausal and Premature Ovarian Insufficiency Women
Menopause, Menopausal Hormone Therapy
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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abaloparatide Transdermal (50 mcg), Abaloparatide Transdermal (100 mcg) and Abaloparatide Transdermal (150 mcg) in people with Post Menopausal Osteoporosis, run by Radius Health, Inc. at 9 sites in 4 countries.
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 4 inclusion and 4 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 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Denmark, Poland, Estonia. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 19 Dec 2016). 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?
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months (time frame: Baseline, 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2020.