A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab

NCT00887965 | Completed Phase 2 Results

• 1 other identifier: 20080287
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

To characterize the effects of discontinuation of denosumab therapy on variables of bone histology in postmenopausal women with low bone mass or osteoporosis. Patients who have received denosumab and completed study 20050179 (NCT00293813), completed study 20050141 (NCT00330460), completed study 20060237 (NCT00515463), completed study 20030216 (NCT00089791) but did not enroll in study 20060289 (NCT00523341) will be included in this study. Patients who will participate in the off-treatment imaging study for 20080747 (NCT00890981) are also eligible.

Conditions

Low Bone Mass; Low Bone Mineral Density; Osteoporosis; Postmenopausal Osteoporosis

Keywords

Low Bone Mass; Low Bone Mineral Density; Osteoporosis; Postmenopausal Osteoporosis; Bone Biopsy; Transiliac Crest Bone Histology; Histomorphometry

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Normal/Abnormal Bone Histology

  The number of participants with normal/abnormal bone histology as assessed by bone biopsy samples at the central histomorphometric facility. Normal bone histology is characterized by: - normal lamellar bone, - normal mineralization or - osteoid (the organic matrix of bone; young bone that has not undergone calcification). Biopsies with abnormal bone histology are characterized by: - osteomalacia, - marrow fibrosis, - clinically significant marrow abnormality or - woven bone.

  25-34 days post-Day 1

Secondary Outcomes (26)

• Bone Histomorphometry: Cancellous Bone Volume

  25-34 days post-Day 1

• Bone Histomorphometry: Trabecular Number

  25-34 days post-Day 1

• Bone Histomorphometry: Trabecular Separation

  25-34 days post-Day 1

• Bone Histomorphometry: Trabecular Thickness

  25-34 days post-Day 1

• Bone Histomorphometry: Cortical Width

  25-34 days post-Day 1

Study Arms (1)

Previous denosumab

OTHER

Participants who had previously received denosumab received a transiliac crest bone biopsy performed following standard labeling procedures with tetracycline or tetracycline derivative.

Drug: Previous denosumab

Interventions

Previous denosumab DRUG

Participants who had previously received denosumab received a transiliac crest bone biopsy performed following standard labeling procedures with tetracycline or tetracycline derivative.

Previous denosumab

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory postmenopausal women
• Received denosumab and completed study 20050179 (NCT00293813), completed study 20050141 (NCT00330460), completed study 20060237 (NCT00515463), completed study 20030216 (NCT00089791) but did not enroll in study 20060289 (NCT00523341). Patients who will participate in the off-treatment imaging study for 20080747 (NCT00890981) also are eligible.
• Completed participation in eligible studies ≥ 12 and ≤ 36 months prior to screening
• Provide signed informed consent

You may not qualify if:

• Did not receive denosumab in studies 20050141, 20060237, 20030216, or 20050179.
• Discontinued investigational product before end of study visit for studies 20050141, 20060237, 20030216, or 20050179.
• Received \> 1 month osteoporosis treatment since having completed studies 20050141, 20060237, 20030216, or 20050179.
• Received zoledronic acid at any time after ending study participation in parent studies 20050141, 20050179, 20030216, or 20060237.
• Newly diagnosed with any of the following conditions during the intervening period since completing studies 20050141, 20060237, 20030216, or 20050179:
• Hyperthyroidism (stable on anti-thyroid therapy or post-ablation is allowed, if the Thyroid Stimulating Hormone is within the normal range)
• Hypothyroidism (stable on thyroid replacement therapy is allowed, if the Thyroid Stimulating Hormone is within the normal range)
• Hyper- or hypoparathyroidism
• Osteomalacia
• Paget's disease of bone
• Other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta)
• Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma).
• Self-reported alcohol or drug abuse within the previous 12 months.
• Permanently non-ambulatory subjects (use of assistive device eg cane, walker is permitted).
• Has known or suspected sensitivity or contraindication to tetracycline derivatives.

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

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

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 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: April 24, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 15, 2013
• Results First Posted: October 17, 2013

Record last verified: 2013-10