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Postmenopausal Women With Osteoporosis | Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

Postmenopausal Women With Osteoporosis research study

What is the primary objective of this study?

The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Postmenopausal Women With Osteoporosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Biological:RomosozumabRomosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.

Drug:AlendronateAlendronate 70 mg tablet taken once a week

Drug:Placebo to RomosozumabAdministered by subcutaneous injection once a month during the double-blind treatment phase.

Drug:Placebo to AlendronateMatching placebo tablet taken once a week during the double-blind treatment phase.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Alendronate/AlendronateParticipants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.

Romosozumab/AlendronateParticipants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Study Status

Completed

Start Date: May 4, 2012

Completed Date: June 29, 2017

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Percentage of Participants With New Vertebral Fractures Through Month 24

Secondary Outcome: Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis

Study sponsors, principal investigator, and references

Principal Investigator: MD

Lead Sponsor: Amgen

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01631214

Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.

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