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.
Bone Histomorphometry: Cancellous Bone VolumeBone Histomorphometry: Trabecular Number
Bone Histomorphometry: Trabecular Separation
Bone Histomorphometry: Trabecular Thickness
Bone Histomorphometry: Cortical Width
Bone Histomorphometry: Surface Density
Bone Histomorphometry: Osteoblast - Osteoid Interface
Bone Histomorphometry: Osteoid Surface
Bone Histomorphometry: Osteoid Width
Bone Histomorphometry: Wall Thickness
Bone Histomorphometry: Eroded Surface/Bone Surface
Bone Histomorphometry: Osteoclast Number - Length Based
Bone Histomorphometry: Osteoclast Number - Surface Based
Bone Histomorphometry: Single-label Surface
Bone Histomorphometry: Double-label Surface
Bone Histomorphometry: Total Mineralizing Surface
Bone Histomorphometry: Mineral Apposition Rate
Bone Histomorphometry: Adjusted Mineral Apposition Rate
Bone Histomorphometry: Bone Formation Rate - Surface Based
Bone Histomorphometry: Bone Formation Rate - Volume Based
Bone Histomorphometry: Formation Period
Bone Histomorphometry: Activation Frequency
Bone Histomorphometry: Osteoid Volume
Bone Histomorphometry: Mineralization Lag Time
C-Telopeptide (CTX-1)
Procollagen Type 1 N-terminal Peptide (P1NP)
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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.