A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab
Condition: Low Bone Mass; Low Bone Mineral Density; Osteoporosis; Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic
Intervention: Previous denosumab
Intervention description: Participants who had previously received denosumab received a transiliac crest bone biopsy performed following standard labeling procedures with tetracycline or tetracycline derivative.
Intervention MeSH terms: Denosumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Healthy volunteers: No
Keywords: Low Bone Mass; Low Bone Mineral Density; Osteoporosis; Postmenopausal Osteoporosis; Bone Biopsy; Transiliac Crest Bone Histology; Histomorphometry

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.
    

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.