Clinical trial NCT00887965: A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab
Official title: A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2009-04-24
Enrollment: 15
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Number of Participants With Normal/Abnormal Bone Histology
timeFrame: 25-34 days post-Day 1
Secondary outcomes:
measure: Bone Histomorphometry: Cancellous Bone Volume
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Trabecular Number
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Trabecular Separation
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Trabecular Thickness
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Cortical Width
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Surface Density
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Osteoblast - Osteoid Interface
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Osteoid Surface
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Osteoid Width
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Wall Thickness
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Eroded Surface/Bone Surface
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Osteoclast Number - Length Based
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Osteoclast Number - Surface Based
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Single-label Surface
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Double-label Surface
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Total Mineralizing Surface
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Mineral Apposition Rate
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Adjusted Mineral Apposition Rate
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Bone Formation Rate - Surface Based
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Bone Formation Rate - Volume Based
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Formation Period
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Activation Frequency
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Osteoid Volume
timeFrame: 25-34 days post-Day 1
measure: Bone Histomorphometry: Mineralization Lag Time
timeFrame: 25-34 days post-Day 1
measure: C-Telopeptide (CTX-1)
timeFrame: Day 3 or Day 20
measure: Procollagen Type 1 N-terminal Peptide (P1NP)
timeFrame: Day 3 or Day 20
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: