Bone Histomorphometry, Microarchitecture and Matrix Structure and Properties in Patients Receiving Long-term Risedronate Treatment - IMPACT Biopsy Registry
- Conditions
- 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: 8.1Level: LLTClassification code 10031285Term: Osteoporosis postmenopausal
- Registration Number
- EUCTR2006-004840-21-AT
- Lead Sponsor
- sanofi-aventis Netherlands B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method