The objective of this study is to collect data on bone histomorphometry, architecture, turnover and material properties from iliac crest biopsies taken from postmenopausal women after > 5 year risedronate treatment. These data will be used as additional data for the primary and secondary objectives from Studies 2003073 and 2003096 for which the recruitment of 28 subjects who had > 5 year risedronate treatment has not been achieved. MedDRA version: 8.1 Level: LLT Classification code 10031285 Te
Conditions
Interventions
Trade Name: Actonel
Product Name: Risedronate
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RISEDRONATE SODIUM
CAS Number: 115436721
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
sanofi-aventis Netherlands B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Women completed the IMPACT study and continued risedronate (any combination of 5 mg daily or 35 mg once weekly) treatment for =5 years and are still on risedronate treatment at study entry. - Self-ambulatory - In general good health as determined by medical history, physical examination and laboratory tests - Willing and able to provide written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - The use of any medication other than risedronate within the past 12 months likely to interfere with skeletal homeostasis, such as estrogen, Selective Estrogen Receptor Modulators, calcitonin, other bisphosphonates, parathyroid hormone, heparin or anticonvulsants - Use of high dose glucocorticoids (= 5 mg/day prednisone or equivalent) for more than one month within 3 months prior to study entry - Uncontrolled hyperthyroidism - History of malignancy except treated squamous cell, or basal cell carcinoma of the skin - Any concurrent disease, which in the opinion of the investigator would inhibit the subject completing the study or would interfere with the outcome measures - Allergy to tetracycline, Novocain, or Versed - Hip anatomy not conducive to transiliac bone biopsy or DXA scan - Previous bilateral transiliac bone biopsies - Refusal or inability to give informed consent to participate in the study - Unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up visits, insurmountable language barrier. - Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to collect data on bone histomorphometry, architecture, turnover and material properties from iliac crest biopsies taken from postmenopausal women after > 5 year risedronate treatment. These data will be used as additional data for the primary and secondary objectives from Studies 2003073 and 2003096. The objectives of studies 2003073 and 2003096 are: Primary objective: To determine the differences in iliac crest bone histomorphometry and bone quality (including bone microarchitecture and bone matrix structure) in postmenopausal women who have received long-term (>3 and 5 years) therapy with alendronate and risedronate Secondary objective: To determine if iliac crest bone histomorphometry and/or bone quality changes after 5 or more years of therapy with alendronate or risedronate compared to 3 years of alendronate therapy or 3 years of risedronate therapy in postmenopausal women ;Secondary Objective: ;Primary end point(s): Measurements on the bone biopsy are: • Standard static and dynamic histomorphometric parameters. • Collagen cross-linking (from FTIR). • Mineral crystallinity (from FTIR). • Mineralization (from qBEI, synchrotron, micro-CT). • Trabecular and cortical architecture (from micro-CT and synchrotron). | — |
Countries
Austria
Outcome results
None listed