Bone Histomorphometry, Microarchitecture and Matrix Structure and Properties in Patients Receiving Long-term Risedronate Treatment - IMPACT Biopsy Registry

sanofi-aventis Netherlands B.V.0 sites20 target enrollmentMay 21, 2007

Overview

No summary available.

Registry

who.int

Start Date

May 21, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

sanofi-aventis Netherlands B.V.

•\- 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.