Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy

NCT00919711 | Completed Phase 3 Results

• 1 other identifier: 20080099
• Study Type: interventional
• Target: 870
• Locations: 0 countries
• Sites: N/A

Brief Summary

A randomized, open label study to assess the safety and effectiveness of Denosumab, administered every 6 months and Actonel ® (Risedronate), administered monthly in post menopausal women transitioned from weekly or daily Alendronate therapy.

Conditions

Osteoporosis

Keywords

Menopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Total Hip BMD Percent Change From Baseline at Month 12

  Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry

  Baseline to month 12

Secondary Outcomes (3)

• Serum CTX Percent Change From Baseline at Month 1

  Baseline to month 1

• Femoral Neck BMD Percent Change From Baseline at Month 12

  Baseline to month 12

• Lumbar Spine BMD Percent Change From Baseline at Month 12

  Baseline to month 12

Study Arms (2)

Denosumab 60 mg

EXPERIMENTAL

Drug: Denosumab

Risedronate 150 mg QM

ACTIVE COMPARATOR

Drug: Actonel®

Interventions

Actonel® DRUG

Oral Actonel® (Risedronate) in total a 150mg per month (one 75mg tablet to be taken on each of 2 consecutive days per month).

Also known as: Risedronate

Risedronate 150 mg QM

Denosumab DRUG

Denosumab 60 mg, once every 6 months, Subcutaneous

Denosumab 60 mg

Eligibility Criteria

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

You may qualify if:

• Ambulatory, post menopausal women aged 55 years or older at screening. Have received their first prescription of daily or weekly alendronate therapy, for the treatment for post menopausal osteoporosis at least 1 month prior to screening. Use of raloxifene, calcitonin or hormone replacement therapy (HRT) prior to alendronate treatment will be allowed. Prior and/or current use of vitamin D and calcium will be allowed.
• Has stopped oral alendronate therapy (is denoted as non-persistent) before the screening visit or, is still taking oral alendronate therapy but does not take on a regular basis (this will be assessed by the completion of a compliance questionnaire at screening).
• Provide signed informed consent before any study-specific procedures are conducted.

You may not qualify if:

• Any prior or current use of medications prescribed for osteoporosis treatment other than oral daily alendronate, calcium and vitamin D. Prior use of raloxifen, calcitonin or HRT before alendronate therapy was started will be allowed.
• Hypersensitivity to Actonel® or any ingredient of Actonel® tablets.
• Contraindicated or poorly tolerant of alendronate therapy.
• Active gastric or duodenal ulcer.
• Known sensitivity to mammalian cell derived products.
• Known intolerance to calcium supplements.
• Malignancy within the last 5 years (except for cervical or basal cell carcinoma).
• Vitamin D deficiency (serum 25-OH vitamin D less than 20ng/mL (equivalent to 49.9 nanomoles per Liter) at screening.
• Current hypo- or hypercalcemia based on the central laboratory reference ranges.
• Uncontrolled hyper- or hypothyroidism (stable on antithyroid therapy or post-ablation is allowed, if the laboratory results from screening show that thyroid stimulating hormone (TSH) is within the normal range).
• Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, Paget's disease of bone that may interfere with the interpretation of the findings.
• Height, weight or girth which may preclude accurate dual x-ray absorptiometry (DXA measurements).
• Fewer than 2 lumbar vertebrae (L1-L4) able to be evaluated by DXA.
• Known to have tested positive for human immunodeficiency virus.
• Previous participation in clinical trials with denosumab within the last 12 months (regardless of treatment).

Sponsors & Collaborators

• Amgen: lead

Related Publications (2)

• Roux C, Hofbauer LC, Ho PR, Wark JD, Zillikens MC, Fahrleitner-Pammer A, Hawkins F, Micaelo M, Minisola S, Papaioannou N, Stone M, Ferreira I, Siddhanti S, Wagman RB, Brown JP. Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: efficacy and safety results from a randomized open-label study. Bone. 2014 Jan;58:48-54. doi: 10.1016/j.bone.2013.10.006. Epub 2013 Oct 17.

  PMID: 24141036 BACKGROUND

• 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

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Osteoporosis; Osteoporosis, Postmenopausal

Interventions

Risedronic Acid; Denosumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 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: June 11, 2009
• First Posted: June 12, 2009
• Study Start: September 1, 2009
• Primary Completion: December 21, 2011
• Study Completion: March 5, 2012
• Last Updated: July 28, 2020
• Results First Posted: December 12, 2012

Record last verified: 2020-03