Osteopenic postmenopausal women MedDRA version: 8.1 Level: LLT Classification code 10031285
Conditions
Interventions
Trade Name: ACTONEL 35 mg, comprimé pelliculé
Product Name: Actonel 35 mg, comprimé pelliculé
Product Code: NA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: risédronate monosodique
Conc
Sponsors
sanofi-aventis Groupe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women meeting all of the following criteria are eligible for randomization into the study: a) ambulatory ; b) between 55 and 75 years of age, inclusive ; c) spontaneous cessation of menstruation since at least 12 months prior to study enrollment d) has osteopenia defined as having the following : EITHER Lumbar spine (L1 through L4) BMD T-score of -1 to -2.5 Hologic: 0.937 g/cm2 to 0.772 g/cm2 Lunar:1.060 g/cm2 to 0.882 g/cm2 AND A total hip T-score of >ou =-2.5 Hologic: >ou= 0.636 g/cm2 Lunar: >ou= 0.693 g/cm2 OR Lumbar spine (L1 through L4) BMD T-score of >ou=-2.5 Hologic: >ou= 0.772 g/cm2 Lunar: >ou= 0.880 g/cm2 AND A total hip T-score of -1 to -2.5 Hologic: 0.819 g/cm2 to 0.636 g/cm2 Lunar: 0.881 g/cm2 to 0.693 g/cm2 e) must have at least 1 evaluable radius and tibia, without history of fracture (traumatic or atraumatic) f) BMI =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will not be admitted into the study if they exhibit any of the following : a) documented history of illicit drug abuse or alcohol abuse (for the past 2 years) ; b) evidence of significant psychiatric or organic disease (particularly a history of malignant disease [excluding skin epitheliomas], gastrointestinal, hepatic, renal, or cardiac disease), which, in the opinion of the investigator and the medical monitor, would prevent the patient from completing the study ; c) history of tremor disorder ; d) history of recent (ou= 3 non-evaluable lumbar vertebrae at lumbar spine L1 – L4) or the femoral neck ; f) clinical or radiological evidence of osteoporosis, such as atraumatic vertebral compression fracture (>ou= 20% reduction in anterior-to-posterior or middle-to-posterior height ratio ; or >ou= 20% reduction of the anterior, middle, and/or posterior height as compared with the adjacent vertebrae) documented by spinal X-ray or a history of osteoporosis-related atraumatic fracture of the hip or of the wrist ; g) glucocorticoid-induced osteopenia ; h) previous IV bisphonate therapy i) oral bisphosphonate therapy for > 3 months in the past 3 years ; j) use of estrogens and/or progestins for > 1 month at any time within the past 12 months ; k) use of any of the following medications for > 1 month at any time within the past 6 months : -corticosteroids or anabolic medications, -calcitonin, -vitamin D (>ou= 1000 IU/day), or -diuretics if not stable since at least 3 months -anticonvulsants ; l) use of fluoride (prescribed in the bone therapeutic range of >ou= 10 mg/day) for > 1 month ; m) current use of any of the following medications : -oral or parenteral glucocorticoids, -anabolic steroids, -estrogens (oral, skin patch, gel, or subcutaneous implant), -estrogen-related medications, such as tamoxifene, selective estrogen receptor modulators (raloxifene), tibolone -progestins, -calcitonin, calcitriol, calcifediol, or alfacalcidol -calcium supplements (> 1g/day) -vitamin D supplements (> 800 IU/day) -vitamin D depot injection (>10,000 IU) -any bisphosphonate (other than the investigational product) used for > 1 month at any time within the past 6 months, -fluoride (>ou= 10 mg/day), -strontium and other bone active agents (ie isoflavones), -PTH at any time within the past 3 years ; or -any other investigational product n) history of any allergic or abnormal reaction to bisphosphonates ; o) severe renal impairment (creatinine clearance < 30mL/min) ; p) serum 25-hydroxy vitamin D level < 15 ng/mL q) markedly abnormal clinical laboratory parameters at screening assessed as clinically significant by the investigator; r) participation in another clinical study 30 days prior to enrollment ; s) demonstrated unlikely to comply with protocol requirements (eg, uncooperative attitude, inability to return for follow-up visits, history of medical non-compliance) and/or poor likelihood of completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare risedronate 35 mg and placebo with respect to percent change at 12-month for distal radius trabecular bone volume (BV/TV) in osteopenic postmenopausal women as measured by 3D-pQCT.;Secondary Objective: The secondary objectives are to compare the percent change from Screening/Baseline between the 2 treatment groups for the following measurements: · BMD of the lumbar spine, femoral neck, femoral trochanter, and total proximal femur using dual-energy X-ray absorptiometry (DXA) scan at 12, and 24 M ; · 3D-pQCT analysis of distal radius and distal tibia bone microarchitecture data at 6, 12, and 24 M ; · Bone turnover markers (BTMs) of fasting serum carboxyterminal cross-linking telopeptide of Type 1 bone collagen (CTX-1), serum aminoterminal propeptide of Type 1 procollagen (PINP) and urine NTX at 3, 6, 12 and 24 M. ;Primary end point(s): 3-D-pQCT Data—Microarchitectural Parameters (Distal Radius BV/TV Measurements) The primary efficacy assessment in this study will be BV/TV percent change from Baseline at distal radius as measured in the non-dominant wrist at Month 12. If there is a history of prior fracture (traumatic or atraumatic) in the non-dominant wrist, the dominant wrist will be used. Measurements will be taken using Xtreme CT scanners supplied by SCANCO Medical AG, (Bassersdorf, Switzerland) who will be responsible for the analysis and central reading of the radiological images. | — |
Countries
France
Outcome results
None listed