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

NCT ID: NCT00887965

Last Updated: 2013-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Previous denosumab

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

Group Type: OTHER

Previous denosumab

Intervention Type: DRUG

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

Interventions

Previous denosumab

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• Received any investigational product other than denosumab.
• Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone analogue, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone.
• Has undergone bilateral transiliac crest bone biopsy in the past.
• Current use of medications that, in the opinion of the investigator, cannot be discontinued and may compromise the safety of the subject when undergoing the bone biopsy procedure (eg, aspirin, warfarin, high-dose heparin).
• Current use of systemic glucocorticoid therapy (topical or nasal steroids are permitted).
• Evidence of coagulopathy that in the opinion of the investigator, may compromise patient safety when subjected to the bone biopsy procedure.
• Any disorder that, in the opinion of the investigator, may compromise the ability of the participant to give written informed consent and/or comply with study procedures.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Countries

Argentina; Canada

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20080287

Identifier Type: -

Identifier Source: org_study_id