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A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab
This study is not yet open for participant recruitment.
Verified by Amgen, April 2009
First Received: April 23, 2009   No Changes Posted
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00887965
  Purpose

To characterize the effects of discontinuation of denosumab therapy on variables of bone histology in postmenopausal women with low bone mass or osteoporosis. Subjects who have received denosumab and completed study 20050179, completed study 20050141, completed study 20060237, completed study 20030216 but did not enroll in study 20060289 will be included in this study. Subjects who will participate in the off-treatment imaging study for 20080747 are also eligible.


Condition Intervention Phase
Low Bone Mass
Low Bone Mineral Density
Osteoporosis
Postmenopausal Osteoporosis
Procedure: Bone Biopsy
Phase II

MedlinePlus related topics: Minerals Osteoporosis
Drug Information available for: Denosumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Open Label, Single Group Assignment, Safety Study
Official Title: A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab

Further study details as provided by Amgen:

Primary Outcome Measures:
  • The primary endpoint is bone histology as part of the qualitative assessment of bone. Normal bone histology will be characterized by normal lamellar bone, mineralization and osteoid as well as absence of osteomalacia, marrow fibrosis or woven bone. [ Time Frame: 25-34 days Post-Day 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Bone histomorphometry variables including cancellous bone volume, trabecular number, separation and thickness, cortical width, surface density, osteoblast-osteoid interface, osteoid surface, width and volume, wall thickness, eroded surface, osteoclast [ Time Frame: 25-34 days Post-Day 1 ] [ Designated as safety issue: Yes ]
  • The biochemical markers of bone turnover CTX-1 and PINP. [ Time Frame: Day 3 or Day 20 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: June 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Procedure: Bone Biopsy
A transiliac crest bone biopsy will be performed following standard labeling procedures with tetracycline (or tetracycline derivative)

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatory postmenopausal women
  • Received denosumab and completed study 20050179, completed study 20050141, completed study 20060237, completed study 20030216 but did not enroll in study 20060289. Subjects who will participate in the off-treatment imaging study for 20080747 also are eligible.
  • Completed participation in eligible studies (4.1.2) ≥ 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.
  • Subjects 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).
  • Subject 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 subject to give written informed consent and/or comply with study procedures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887965

Contacts
Contact: Amgen Call Center 866-572-6436

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20080287
Study First Received: April 23, 2009
Last Updated: April 23, 2009
ClinicalTrials.gov Identifier: NCT00887965     History of Changes
Health Authority: Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica);   Argentina: Ministry of Health;   Canada: Health Canada;   United States: Food and Drug Administration

Keywords provided by Amgen:
Low Bone Mass
Low Bone Mineral Density
Osteoporosis
Postmenopausal Osteoporosis
Bone Biopsy
Transiliac Crest Bone Histology
Histomorphometry

Study placed in the following topic categories:
Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Tetracycline
Bone Diseases

Additional relevant MeSH terms:
Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on May 06, 2009