A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis
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|ClinicalTrials.gov Identifier: NCT02016716|
Recruitment Status : Completed
First Posted : December 20, 2013
Results First Posted : November 8, 2018
Last Update Posted : November 8, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Postmenopausal Osteoporosis||Drug: Romosozumab 90 mg/mL Drug: Placebo 90 mg/mL Drug: Romosozumab 70 mg/mL Drug: Placebo 70 mg/mL||Phase 3|
Upon confirmation of eligibility, participants were randomized in a 22:5:22:5 ratio to the following treatment groups:
- Romosozumab 90 mg/mL
- Placebo 90 mg/mL
- Romosozumab 70 mg/mL
- Placebo 70 mg/mL
After completing a 6-month treatment period, participants entered a 3-month follow-up period with an end of study (EOS) at month 9.
For the analysis of efficacy endpoints, the 2 placebo groups were combined into a single placebo group. For safety analyses, the data for placebo were presented separately for each group.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||294 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Randomized, Multiple-dose Phase 3 Study to Evaluate the Noninferiority of Romosozumab at a 90 mg/mL Concentration Compared With a 70 mg/mL Concentration in Postmenopausal Women With Osteoporosis|
|Actual Study Start Date :||December 3, 2013|
|Actual Primary Completion Date :||September 8, 2014|
|Actual Study Completion Date :||December 8, 2014|
Experimental: Romosozumab 90 mg/mL
Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous (SC) 1.17 mL injections of a 90 mg/mL solution, for 6 months.
Drug: Romosozumab 90 mg/mL
Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS).
Experimental: Placebo 90 mg/mL
Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months.
Drug: Placebo 90 mg/mL
Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS.
Experimental: Romosozumab 70 mg/mL
Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1.0 mL injections of a 70 mg/mL solution, for 6 months.
Drug: Romosozumab 70 mg/mL
Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS.
Placebo Comparator: Placebo 70 mg/mL
Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months.
Drug: Placebo 70 mg/mL
Placebo administered as 3 SC injections with the 1.0 mL glass PFS.
- Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine [ Time Frame: Baseline and month 6 ]Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
- Percent Change From Baseline in Total Hip BMD [ Time Frame: Baseline and month 6 ]Total hip BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline total hip BMD T-score.
- Percent Change From Baseline in Femoral Neck BMD [ Time Frame: Baseline and month 6 ]Femoral neck BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline femoral neck BMD T-score.
- Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP) [ Time Frame: Baseline, month 1, month 3, and month 6 ]
- Percent Change From Baseline in Serum C-Telopeptide (CTX) [ Time Frame: Baseline, month 1, month 3, and month 6 ]
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|Ages Eligible for Study:||55 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
Postmenopausal women with osteoporosis at high risk for fracture defined as
- BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck AND
- a history of fragility fracture or at least 2 other risk factors
- BMD T score < -3.50 at the total hip or femoral neck.
- History of hip fracture.
- History of metabolic or bone disease (except osteoporosis).
- Use of agents affecting bone metabolism.
- Vitamin D insufficiency.
- History of solid organ or bone marrow transplants.
- Hyper- or hypocalcemia.
- Hyper- or hypothyroidism.
- Hyper- or hypoparathyroidism.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016716
|United States, Georgia|
|Gainesville, Georgia, United States, 30501|
|United States, Maryland|
|Bethesda, Maryland, United States, 20817|
|Brno, Czechia, 602 00|
|Klatovy, Czechia, 339 01|
|Uherske Hradiste, Czechia, 686 01|
|Gdynia, Poland, 81-384|
|Gliwice, Poland, 44-100|
|Katowice, Poland, 40-040|
|Kraków, Poland, 31-501|
|Swidnik, Poland, 21-040|
|Warszawa, Poland, 01-192|
|Wroclaw, Poland, 50-088|
|Other Study ID Numbers:||
2013-000434-35 ( EudraCT Number )
|First Posted:||December 20, 2013 Key Record Dates|
|Results First Posted:||November 8, 2018|
|Last Update Posted:||November 8, 2018|
|Last Verified:||September 2018|
Bone Diseases, Metabolic
Physiological Effects of Drugs