Loading clinical trials...

A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates

A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates

NCT00936897•Amgen

View on ClinicalTrials.gov

Summary

This is a multi-center, randomized, open-label, parallel group, study being conducted in the United States and in Europe in postmenopausal women. Approximately 800 subjects will be randomized across about 65 sites in a 1:1 ratio to either denosumab 60mg SC Q6M, or ibandronate 150mg PO QM.

Eligibility

Age

55 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Ambulatory, postmenopausal women (based on medical history) 55 years or older at screening
•Postmenopause will be defined as no vaginal bleeding or spotting for at least 12 months
•If the subject is 55 - 59 years old and there is uncertainty regarding menopausal status, confirmation of serum FSH (\>= 50 mIU/mL) and serum estradiol (\<= 20 pg/mL) must be obtained
•If the subject is 60 years or older, evaluation of FSH and estradiol levels is not needed to confirm menopausal status
•Have received their first prescription of daily or weekly bisphosphonate therapy at least 1 month prior to screening
•May have received
•raloxifene, calcitonin, prior to initiation of daily orweekly bisphosphonate therapy.
•up to 3 doses of monthly bisphosphonate prior to initiation of daily or weekly bisphosphonate therapy
•calcium, and vitamin D
•Hormone replacement therapy (e.g. estrogen use for mitigation of menopausal symptoms)
+9 more criteria

Exclusion Criteria

•Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
•Current or prior use of medications prescribed for osteoporosis treatment other than oral daily or weekly bisphosphonate
•Contraindicated to receive oral ibandronate 150mg PO QM, including
•Hypersensitivity to ibandronate 150mg PO QM or other constituents of ibandronate 150mg PO QM tablets
•Abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia
•Inability to stand or sit upright for at least 60 minutes
•Administration of any of the following treatments within 3 months of screening
•Tibolone
•Anabolic steroids or testosterone
•Glucocorticosteroids (\>= 5 mg prednisone equivalent per day for more than 10 days or a total cumulative dose of \>= 50 mg)
+16 more criteria

Key Dates

Start Date

July 1, 2009

Primary Completion Date

November 1, 2011

Completion Date

January 1, 2012

Last Updated

February 11, 2013

Enrollment

833

ACTUAL participants

Conditions

Postmenopausal Osteoporosis

Interventions

Ibandronate

DRUG

Denosumab

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: February 11, 2013Data 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.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates

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