Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00353080

Enrollment

171

Registered

2006-07-17

Start date

2002-12-31

Completion date

2005-04-30

Last updated

2009-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Postmenopausal

Keywords

Prevention of postmenopausal osteoporosis

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

Interventions

DRUGrisedronate (HMR4003)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA.	—

Secondary

Measure	Time frame
Percent changes in proximal femur BMD from baseline at month 12 and 24 (DXA)	—
Percent of responders (subjects with a positive change in lumbar spine BMD from baseline)at Month 12 and 24	—
Percent changes in bone turnover markers after 12 and 24 months of treatment	—
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	—
Occurrence of adverse events at each visit with special interest for upper gastro-intestinal events	—

Countries

Finland, Netherlands, Norway, Spain, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026