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

Amgen

Status and phase: Completed; Phase 2

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

Treatments: Drug: Previous denosumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00887965

20080287

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Previous denosumab

Other group

Description:

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

Treatment:

Drug: Previous denosumab