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Clinical trial

A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

ID
Name
20110142
Description
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.
Trial arms
Trial start
2012-05-04
Estimated PCD
2017-02-27
Trial end
2017-06-29
Status
Completed
Phase
Early phase I
Treatment
Romosozumab
Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.
Arms:
Romosozumab/Alendronate
Other names:
AMG 785, Evenity
Alendronate
Alendronate 70 mg tablet taken once a week
Arms:
Alendronate/Alendronate, Romosozumab/Alendronate
Other names:
Fosamax
Placebo to Romosozumab
Administered by subcutaneous injection once a month during the double-blind treatment phase.
Arms:
Alendronate/Alendronate
Placebo to Alendronate
Matching placebo tablet taken once a week during the double-blind treatment phase.
Arms:
Romosozumab/Alendronate
Size
4093
Primary endpoint
Percentage of Participants With New Vertebral Fractures Through Month 24
24 months
Percentage of Participants With a Clinical Fracture at the Primary Analysis
The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Eligibility criteria
Inclusion Criteria: Postmenopausal women who meet at least one of the following bone mineral density (BMD) and fracture criteria: * BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER: * at least 1 moderate (semiquantitative grade \[SQ\]2) or severe (SQ3) vertebral fracture OR * at least 2 mild (SQ1) vertebral fractures OR * BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER: * at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR * a fracture of the proximal femur that occurred within 3 to 24 months prior to randomization. Exclusion Criteria: * 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 * Possible signs of intolerance to alendronate
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 4093, 'type': 'ACTUAL'}}
Updated at
2022-11-08

1 organization

2 products

1 indication

Product
Romosozumab
Organization
Amgen
Indication
Postmenopausal Women With Osteoporosis
Product
Alendronate