Clinical trial NCT00353080: Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women
Official title: A Two-year, Multicenter, Double-blind, Randomized, Placebo-controlled and Parallel Group Study of Oral Risedronate 5 mg Daily in the Prevention of Osteoporosis in Osteopenic Postmenopausal Women (More Than 5 Years Postmenopausal)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis, Postmenopausal
Keywords: Prevention of postmenopausal osteoporosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Procter and Gamble
First posted: 2006-07-17
Enrollment: 171
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women

To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption

To confirm general safety of 5 mg daily risedronate as compared to placebo


Eligibility criteria: Inclusion Criteria:

* Ambulatory, healthy postmenopausal women with

  * Natural menopause and more than 5 years after their last menstrual period
  * or surgical menopause and more than 5 years after surgery
  * osteopenia (lumbar spine T score between 1 and 2.5 SD below the mean value in normal young women).
* With at least one risk factor for osteoporosis

Exclusion Criteria:

* Women who have received hormone replacement therapy (with estrogen and/or progestogen and/or androgen) or raloxifene within 3 months before visit 2 or calcitonin or calcitriol within 4 weeks before visit 2

Primary outcomes:
measure: Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA.
Secondary outcomes:
measure: Percent changes in proximal femur BMD from baseline at month 12 and 24 (DXA)
measure: Percent of responders (subjects with a positive change in lumbar spine BMD from baseline)at Month 12 and 24
measure: Percent changes in bone turnover markers after 12 and 24 months of treatment
measure: Physical examination and hematology tests before and after 12 and 24 months of treatment;Serum Chemistry before and after 6, 12 and 24 months of treatment
measure: Occurrence of adverse events at each visit with special interest for upper gastro-intestinal events
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Sanofi-Aventis
city: Gouda
country: Netherlands
facility: Sanofi-Aventis
city: Oslo
country: Norway
facility: Sanofi-Aventis
city: Madrid
country: Spain
facility: Sanofi-Aventis
city: Stockholm
country: Sweden
facility: Sanofi-Aventis
Study officials:
affiliation: Division of Endocrinology, Helsinki University Central Hospital, Helsinki, Finland
name: Välimäki Matti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valimaki MJ, Farrerons-Minguella J, Halse J, Kroger H, Maroni M, Mulder H, Munoz-Torres M, Saaf M, Snorre Ofjord E. Effects of risedronate 5 mg/d on bone mineral density and bone turnover markers in late-postmenopausal women with osteopenia: a multinational, 24-month, randomized, double-blind, placebo-controlled, parallel-group, phase III trial. Clin Ther. 2007 Sep;29(9):1937-49. doi: 10.1016/j.clinthera.2007.09.017.