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A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis | Clinical Trials | Clareo Health

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A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

A Multicenter, Double-blind, Randomized Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

NCT02157948•Amgen

View on ClinicalTrials.gov

Summary

This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.

Eligibility

Age

55 - 100 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Subject has provided informed consent prior to any study-specific activities/procedures
•Ambulatory postmenopausal women.
•Age 55 years or older
•Screening BMD value equivalent to a T-score less than or equal to -2.5 at the lumbar spine, total hip, or femoral neck.

Exclusion Criteria

•Administration of osteoporosis treatments or bone active treatments within specific timeframes
•Vitamin D deficiency
•Diseases and conditions that affect bone metabolism (e.g., hypo/hyper-parathyroidism; hypo/hyperthyroidism, unless stable and well-controlled)
•Contraindications to denosumab therapy (e.g., hypocalcemia)

Locations (23)

Research Site

Santa Maria, California, United States

Research Site

South Lake Tahoe, California, United States

Research Site

Lakewood, Colorado, United States

Research Site

Gainesville, Georgia, United States

Research Site

Bethesda, Maryland, United States

Research Site

Detroit, Michigan, United States

Research Site

Albuquerque, New Mexico, United States

Research Site

Akron, Ohio, United States

Research Site

Bend, Oregon, United States

Research Site

Duncansville, Pennsylvania, United States

Key Dates

Start Date

May 1, 2014

Primary Completion Date

July 1, 2015

Completion Date

July 1, 2015

Last Updated

August 16, 2017

Enrollment

394

ACTUAL participants

Conditions

Postmenopausal Osteoporosis

Interventions

Denosumab (CP2)

DRUG

Denosumab (CP4)

DRUG

Anabolic Therapy in Postmenopausal Osteoporosis

NCT05010590

Postmenopausal Osteoporosis

View study

NOT_YET_RECRUITING

AGE Burden and Response to Antiresorptive Therapy in Osteoporosis

NCT07329543

OsteoporosisPostmenopausal Osteoporosis

View study

WITHDRAWNNA

Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 16, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

Inclusion Criteria

Exclusion Criteria

Anabolic Therapy in Postmenopausal Osteoporosis

AGE Burden and Response to Antiresorptive Therapy in Osteoporosis

Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis

A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis

Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis