Transition From Alendronate to Romosozumab (AMG 785)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-30

Study Completion Date

2012-11-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to estimate the percent change from baseline in lumbar spine bone mineral density (BMD) following multiple-dose administrations of romosozumab in postmenopausal women with low BMD previously treated with alendronate.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density

NCT00896532

Low Bone Mineral Density Postmenopausal Osteoporosis

COMPLETED PHASE2

Study of Transitioning From Alendronate to Denosumab

NCT00377819

Postmenopausal Osteoporosis

COMPLETED PHASE3

A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis

NCT02186171

Osteoporosis in Men

COMPLETED PHASE3

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

NCT01631214

Postmenopausal Women With Osteoporosis

COMPLETED PHASE3

A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis

NCT02016716

Postmenopausal Osteoporosis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Romosozumab 140 mg

Participants received romosozumab 140 mg administered subcutaneously once a month for 3 months.

Group Type EXPERIMENTAL

Romosozumab

Intervention Type DRUG

Administered by subcutaneous injection

Romosozumab 210 mg

Participants received romosozumab 210 mg administered subcutaneously once a month for 3 months.

Group Type EXPERIMENTAL

Romosozumab

Intervention Type DRUG

Administered by subcutaneous injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Romosozumab

Administered by subcutaneous injection

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AMG 785 EVENITY™

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Postmenopausal women, defined as no vaginal bleeding or spotting for ≥ 12 months
* Low bone mineral density at screening \[defined by a bone mineral density (BMD) T-score ≤ -2.0 and ≥ -4.0 at the lumbar spine (L1 to L4; or BMD T-score of evaluable vertebrae), total hip, or femoral neck\]
* Currently taking alendronate (70 mg weekly or equivalent) exclusively for ≥ 1 year with verbal agreement that the subject has taken ≥ 80% of their doses with good tolerance

Exclusion Criteria

* History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis after age 50; or recent bone fracture within 6 months prior to screening
* History of metabolic or bone disease such as Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome
* Vitamin D deficiency (defined as 25-OH-VitD levels \< 20 ng/mL)

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No