OsteoporosisPhase 2NCT01144377
A Study of LY2541546 in Women With Low Bone Mineral Density
A Phase 2 study testing LY2541546 in people with Osteoporosis, run by Eli Lilly and Company at 8 sites in 5 countries.
Trial summary
The primary objectives of this study include evaluating the dose response of LY2541546 using bone mineral density (BMD) change from baseline as compared to placebo and evaluating the overall safety and tolerability of LY2541546 following multiple subcutaneous administrations in postmenopausal (PMP) women with low BMD. Read more about this study
- Who is it for?
- Ages 45 to 85 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- LY2541546
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Aug 2010to Feb 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 45 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory, postmenopausal women, inclusive.
- Have low bone mineral density (BMD), defined as a T-score or equivalent BMD absolute value (grams/square centimeter [g/cm^2]) for the lumbar spine of between -3.5 and -2.0, inclusive.
- Without language barrier, reliable, and willing to make themselves available for the duration of the study and to follow study procedures.
- Willing to take study drug and daily supplements (calcium and Vitamin D).
- Normal laboratory tests or laboratory test results determined not clinically significant by the investigator. Serum phosphate and serum calcium must be within normal limits, and platelet level greater than 100,000 cubic millimeters (mm^3).
Who cannot join
- Have received treatment with any of the following medications more recently than 3 months prior to screening Androgen, Calcitonin, Estrogen (including over the counter preparations known to have estrogenic activity), Progestin (including over the counter preparations known to have progestogenic activity), selective estrogen receptor modulators (SERMs) (Raloxifene, Tamoxifen, Toremifene, Clomiphene), or Tibolone.
- Have previously used or currently use denosumab, parathyroid hormone (PTH) and/or PTH analogs, strontium ranelate, or parenteral formulations of bisphosphonates.
- Have received treatment with any oral bisphosphonate within the last year.
- Have received therapeutic doses of systemic corticosteroids for more than one month during the 6 months prior to screening.
- Have received therapeutic doses of fluorides (20 milligrams per day) for more than 3 months during the last 3 years, or for more than a total of 2 years, or any within the last 6 months.
- Have severe Vitamin D deficiency defined as 25-hydroxyvitamin D less than <9.2 nanograms per milliliter (ng/mL) [23 nanomoles per liter (nmol/L)] at screening. If the serum 25-hydroxy-vitamin D level at screening is less than or equal to 9.2 ng/mL and <20 ng/mL, participants will receive a loading dose of Vitamin D (at a dose of approximately 100,000 international units (IU) given orally) prior to enrollment.
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- Have any known bone disorder other than low BMD or osteoporosis.
- Have a history of osteoporotic fractures, including known prevalent vertebral fracture or evidence of prevalent vertebral fracture on screening spine X-ray or dual-energy x-ray absorptiometry (DXA), or are considered to be at high risk for fracture.
- Presence of any abnormality (such as artifacts or osteophytes) that would confound DXA evaluation of lumbar vertebrae in the L-1 through L-4 region.
- Have a history of Bell's palsy, other cranial nerve disorders, or have a history of Temporomandibular Joint and Muscle Disorders (TMJDs).
- Have any history of cancer within the previous 5 years, except for excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.
- Have history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of constituting a risk when taking the study medication or of interfering with the interpretation of data.
- Have acute or chronic liver disease ([bilirubin >34 micromoles per liter (µmol/L) or >2.0 milligrams per deciliter (mg/dL), alanine transaminase [ALT/SGPT] >100 units per liter (U/L), or alkaline phosphatase >300 U/L)].
- Have impaired kidney function serum creatinine >135 µmol/L or >2.0 mg/dL.
- Have known allergy to LY2541546, any of diluents or excipients of LY2541546, or significant allergy to any other monoclonal antibody.
- History of excessive consumption of alcohol or abuse of drugs within the last year.
- Have poor medical condition or psychiatric risks for treatment with an investigational drug.
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
United States2 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bethesda, Maryland, 20817
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gainesville, Georgia, 30501
Denmark2 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hvidovre, 2650
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vejle, 7100
Japan2 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nagano, 386-0493
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tokyo, 166-0003
Estonia1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tallinn, 10128
Lithuania1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vilnius, 10323
About this study
Official title: A Phase 2 Randomized Study of LY2541546 Versus Placebo in Postmenopausal Women With Low Bone Mineral Density: An Evaluation of the Dose Response Relationship Using Bone Mineral Density
The primary objectives of this study include evaluating the dose response of LY2541546 using bone mineral density (BMD) change from baseline as compared to placebo and evaluating the overall safety and tolerability of LY2541546 following multiple subcutaneous administrations in postmenopausal (PMP) women with low BMD. Following the last dose of study drug, participants will be able to participate in a 12 month extension to collect additional safety and efficacy data (no further treatment will be administered during this extension).
- Conditions
- Osteoporosis
- Being tested
- LY2541546, Placebo
- Keywords
- osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2541546Drug
Also called Blosozumab
Administered subcutaneously
PlaceboDrug
Administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| 180 mg LY2541546 Q4W + Placebo | Experimental | LY2541546: 180 milligrams (mg) administered subcutaneously every 4 weeks (Q4W) for 52 weeks.
Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. Receives: Drug: LY2541546; Drug: Placebo |
| 180 mg LY2541546 Q2W | Experimental | LY2541546: 180 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) for 52 weeks. Receives: Drug: LY2541546 |
| 270 mg LY2541546 Q2W | Experimental | LY2541546: 270 milligrams (mg) LY2541546 administered subcutaneously every 2 weeks (Q2W) for 52 weeks. Receives: Drug: LY2541546 |
| 270 mg LY2541546 Q12W + Placebo | Experimental | LY2541546: 270 milligrams (mg) administered subcutaneously every 12 weeks (Q12W) for 52 weeks.
Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. Receives: Drug: LY2541546; Drug: Placebo |
| Placebo Comparator Q2W | Placebo comparator | Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD)
Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).
Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.
Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate.
Measured: Baseline, 52 weeks
Secondary outcomes (7)
Change From Baseline to 12, 24, and 64 Weeks in Lumbar Spine Bone Mineral Density (BMD)
Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).
Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.
Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate
Measured: Baseline, 12 weeks and 24 weeks and 64 weeks
Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)
Femoral neck and total hip bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).
Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.
Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline BMD as a covariate.
Measured: Baseline, 24 weeks and 52 weeks and 64 weeks
Change From Baseline to 52 Week Endpoint in Wrist Bone Mineral Density (BMD)
Total radius of the wrist bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).
Least squares (LS) mean values were determined using a 1-factor analysis of covariance model with treatment group as the main effect and baseline BMD as a covariate.
Measured: Baseline, 52 weeks
Change From Baseline to 52 Week Endpoint in Bone-specific Alkaline Phosphatase (BSAP)
Measured: Baseline, 52 weeks
Change From Baseline to 52 Week Endpoint in Serum Type I Collagen Fragment (CTx)
Measured: Baseline, 52 weeks
Change From Baseline to 52 Week Endpoint in Osteocalcin
Measured: Baseline, 52 weeks
Change From Baseline to 52 Week Endpoint in Serum N-terminal Extension Propeptide of Type I Collagen (P1NP)
Measured: Baseline, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2012
- Study completionFeb 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 OsteoporosisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144377
- Sponsor's protocol ID
- 11953
- Other IDs
- I2M-MC-GSDB
- Status last verified
- Sep 2019
- First submitted
- 11 Jun 2010
- Last updated
- 17 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Study of LY2541546 Versus Placebo in Postmenopausal Women With Low Bone Mineral Density: An Evaluation of the Dose Response Relationship Using Bone Mineral Density
- ClinicalTrials.gov ID
- NCT01144377
- Acronym / sponsor ID
- 11953
- Conditions
- Osteoporosis
- Keywords
- osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Jun 2010 (estimated)
- Results
- Posted 4 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study include evaluating the dose response of LY2541546 using bone mineral density (BMD) change from baseline as compared to placebo and evaluating the overall safety and tolerability of LY2541546 following multiple subcutaneous administrations in postmenopausal (PMP) women with low BMD. Following the last dose of study drug, participants will be able to participate in a 12 month extension to collect additional safety and efficacy data (no further treatment will be administered during this extension).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 180 mg LY2541546 Q4W + Placebo | Experimental | Drug: LY2541546, Drug: PlaceboLY2541546: 180 milligrams (mg) administered subcutaneously every 4 weeks (Q4W) for 52 weeks. Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. |
| 180 mg LY2541546 Q2W | Experimental | Drug: LY2541546LY2541546: 180 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) for 52 weeks. |
| 270 mg LY2541546 Q2W | Experimental | Drug: LY2541546LY2541546: 270 milligrams (mg) LY2541546 administered subcutaneously every 2 weeks (Q2W) for 52 weeks. |
| 270 mg LY2541546 Q12W + Placebo | Experimental | Drug: LY2541546, Drug: PlaceboLY2541546: 270 milligrams (mg) administered subcutaneously every 12 weeks (Q12W) for 52 weeks. Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. |
| Placebo Comparator Q2W | Placebo comparator | Drug: PlaceboPlacebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ambulatory, postmenopausal women, inclusive.
- Have low bone mineral density (BMD), defined as a T-score or equivalent BMD absolute value (grams/square centimeter [g/cm^2]) for the lumbar spine of between -3.5 and -2.0, inclusive.
- Without language barrier, reliable, and willing to make themselves available for the duration of the study and to follow study procedures.
- Willing to take study drug and daily supplements (calcium and Vitamin D).
- Normal laboratory tests or laboratory test results determined not clinically significant by the investigator. Serum phosphate and serum calcium must be within normal limits, and platelet level greater than 100,000 cubic millimeters (mm^3).
Key exclusion criteria (17 listed)
- Have received treatment with any of the following medications more recently than 3 months prior to screening Androgen, Calcitonin, Estrogen (including over the counter preparations known to have estrogenic activity), Progestin (including over the counter preparations known to have progestogenic activity), selective estrogen receptor modulators (SERMs) (Raloxifene, Tamoxifen, Toremifene, Clomiphene), or Tibolone.
- Have previously used or currently use denosumab, parathyroid hormone (PTH) and/or PTH analogs, strontium ranelate, or parenteral formulations of bisphosphonates.
- Have received treatment with any oral bisphosphonate within the last year.
- Have received therapeutic doses of systemic corticosteroids for more than one month during the 6 months prior to screening.
- Have received therapeutic doses of fluorides (20 milligrams per day) for more than 3 months during the last 3 years, or for more than a total of 2 years, or any within the last 6 months.
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 |
|---|---|---|
| LY2541546Also: BlosozumabAdministered subcutaneously | Drug | 180 mg LY2541546 Q2W, 180 mg LY2541546 Q4W + Placebo, 270 mg LY2541546 Q12W + Placebo, 270 mg LY2541546 Q2W |
| PlaceboAdministered subcutaneously | Drug | 180 mg LY2541546 Q4W + Placebo, 270 mg LY2541546 Q12W + Placebo, Placebo Comparator Q2W |
Primary outcome
Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD)
Time frame: Baseline, 52 weeks
Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance. Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate.
7 secondary outcomes
Change From Baseline to 12, 24, and 64 Weeks in Lumbar Spine Bone Mineral Density (BMD)
Time frame: Baseline, 12 weeks and 24 weeks and 64 weeks
Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)
Time frame: Baseline, 24 weeks and 52 weeks and 64 weeks
Change From Baseline to 52 Week Endpoint in Wrist Bone Mineral Density (BMD)
Time frame: Baseline, 52 weeks
Change From Baseline to 52 Week Endpoint in Bone-specific Alkaline Phosphatase (BSAP)
Time frame: Baseline, 52 weeks
Change From Baseline to 52 Week Endpoint in Serum Type I Collagen Fragment (CTx)
Time frame: Baseline, 52 weeks
Change From Baseline to 52 Week Endpoint in Osteocalcin
Time frame: Baseline, 52 weeks
Change From Baseline to 52 Week Endpoint in Serum N-terminal Extension Propeptide of Type I Collagen (P1NP)
Time frame: Baseline, 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY2541546 in people with Osteoporosis, run by Eli Lilly and Company at 8 sites in 5 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 5 inclusion and 17 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 17 Sep 2019. 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, Denmark, Japan, Estonia, Lithuania. 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 4 Dec 2017). 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?
Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD) (time frame: Baseline, 52 weeks). 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 17 Sep 2019.