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

NCT00936897 | Completed Phase 3 Results

• 1 other identifier: 20080562
• Study Type: interventional
• Target: 833
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Total Hip Bone Mineral Density Percent Change From Baseline at Month 12

  Baseline to month 12

Secondary Outcomes (3)

• Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1

  Baseline to month 1

• Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12

  Baseline to Month 12

• Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12

  Baseline to month 12

Study Arms (2)

Ibandronate

ACTIVE COMPARATOR

Ibandronate 150mg PO QM (tablet)

Drug: Ibandronate

Denosumab

EXPERIMENTAL

denosumab 60mg Subcutaneous Q6M (pre-filled syringe)

Drug: Denosumab

Interventions

Ibandronate DRUG

Ibandronate 150mg PO QM (tablet)

Ibandronate

Denosumab DRUG

denosumab 60mg SC Q6M (pre-filled syringe)

Denosumab

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Subject has:
• Stopped daily or weekly bisphosphonate therapy (is denoted as non-persistent) at least one month before the screening visit, or
• Demonstrated low adherence to therapy assessed by a score of less than 6 on the OS-MMAS
• Screening BMD (g/cm2) values, at the lumbar spine OR total hip, that occur within the following ranges, based on the particular scanner that is used:
• GE Lunar Lumbar spine 0.700 \< or = BMD \< and = 0.940 Total hip 0.504 \< or = BMD \< or = 0.756

You may not qualify if:

• 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)
• Vitamin D deficiency \[25(OH) vitamin D level \< 20 ng/mL (\<49.9 nmol/L)\] - Repletion will be allowed and subjects may be re-screened
• Evidence of any of the following per subject report, chart review or central laboratory result:
• Significantly impaired renal function as determined by estimated Glomerular Filtration Rate less that 30mL/min/1.73 m2 determined by the central laboratory
• Current hypo- or hypercalcemia based on the central laboratory reference ranges
• Active gastric or duodenal ulcer; or any history of significant gastrointestinal bleed requiring hospitalization or transfusion

Sponsors & Collaborators

• Amgen: lead

Related Publications (2)

• Miller PD, Pannacciulli N, Malouf-Sierra J, Singer A, Czerwinski E, Bone HG, Wang C, Huang S, Chines A, Lems W, Brown JP. Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates. Osteoporos Int. 2020 Jan;31(1):181-191. doi: 10.1007/s00198-019-05233-x. Epub 2019 Nov 28.

  PMID: 31776637 DERIVED

• Recknor C, Czerwinski E, Bone HG, Bonnick SL, Binkley N, Palacios S, Moffett A, Siddhanti S, Ferreira I, Ghelani P, Wagman RB, Hall JW, Bolognese MA, Benhamou CL. Denosumab compared with ibandronate in postmenopausal women previously treated with bisphosphonate therapy: a randomized open-label trial. Obstet Gynecol. 2013 Jun;121(6):1291-1299. doi: 10.1097/AOG.0b013e318291718c.

  PMID: 23812464 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Ibandronic Acid; Denosumab

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 10, 2009
• Study Start: July 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2012
• Last Updated: February 11, 2013
• Results First Posted: November 29, 2012

Record last verified: 2013-02