Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00549965
Other study ID # HMR4003B_4035
Secondary ID
Status Completed
Phase Phase 4
First received October 24, 2007
Last updated October 26, 2007
Start date October 2003

Study information

Verified date October 2007
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Compare subject satisfaction of once a week dosing of 35 mg Risedronate to once daily dosing of 5 mg Risedronate in postmenopausal osteoporotic women. Secondary objectives are to measure compliance (50 % drug taken), and persistence.


Recruitment information / eligibility

Status Completed
Enrollment 202
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 55 Years to 80 Years
Eligibility Inclusion Criteria:

- Five (5) years or greater postmenopausal who present with a diagnosis of postmenopausal osteoporosis based on standard clinical practice criteria.

- Subjects must discontinue bisphosphonates, calcitonin, fluoride, glucocorticoids (> than or = to 5 mg prednisone or equivalent per day) and hormone replacement therapy including estrogen-related compounds at least 6 months prior to randomization. During the study, these drugs are not permitted other than the study medication, Risedronate.

- Other concomitant medications should be kept to a minimum, but if the drugs are considered necessary for the subject's welfare and are unlikely to interfere with study medication they may be given at the discretion of the Investigator.

Exclusion Criteria:

- Had a history of cancer within the past 5 years. Relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an exclusion if the subject has been in remission for at least 6 months prior to enrollment.

- Diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism.

- History of alcohol and/or drug abuse.

- Subjects will be excluded for active gastrointestinal disease that may interfere with absorption or with ability to swallow an oral medication.

- Subjects will also be excluded for serious concurrent illness that would interfere with their ability to participate in the trial.

- Excluded medications: bisphosphonates, calcitonin or fluoride or hormone replacement therapy within the last 6 months.

- Known hypersensitivity to bisphosphonates and/or excipients.

- Abnormal laboratory parameters, which are clinically relevant according to the Investigator (including renal insufficiency; creatinine clearance < 30 mL/min)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Risedronate Sodium


Locations

Country Name City State
Korea, Republic of Sanofi-Aventis Daegu

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of subject satisfaction of once a week 35 mg Risedronate and once daily 5 mg Risedronate. A subject-administered questionnaire at 12 and 24 weeks will assess satisfaction.
Secondary The subjects' compliance and persistence on treatment. Compliance as defined by more than 50% of the drug taken (by tablet count) during each Risedronate treatment period. Persistence at week 12 and 24 will be defined as continuing Risedronate treatment.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03931109 - Circulating miRNA in Primary Hyperparathyroidism
Not yet recruiting NCT03232476 - Effect of Mechanical Loading With PTH on Cortical Bone Phase 4
Completed NCT02884401 - Peri-implant Bone Changes in Post-menopausal Osteoporotic Women N/A
Completed NCT00073190 - Patient- and Physician-Based Osteoporosis Education Phase 1
Completed NCT00402441 - Risedronate in the Prevention of Osteoporosis in Postmenopausal Women Phase 4
Completed NCT03710889 - Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption Phase 3
Completed NCT00010712 - Effects of Black Cohosh on Menopausal Hot Flashes Phase 2
Recruiting NCT05058976 - Romosozumab Use to Build Skeletal Integrity Phase 4
Active, not recruiting NCT05405894 - Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
Recruiting NCT03337971 - Nutritional Supplement and Bone Health in Post-Menopausal Women N/A
Completed NCT03701113 - Milk Protein and Bone Health in Postmenopausal Women N/A
Completed NCT01381588 - The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women N/A
Completed NCT00383422 - Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis Phase 3
Completed NCT00035256 - Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis Phase 4
Completed NCT01386281 - Julina Post-marketing Surveillance for Climacteric Symptoms in Japan
Completed NCT05266261 - Use of Ibandronate in Diabetic Patients N/A
Recruiting NCT04964388 - Effect of GLP-1 Receptor Agonists on Trabecular Bone Score Phase 2
Active, not recruiting NCT03623633 - Comparative Antiresorptive Efficacy Discontinuation of Denosumab Phase 4
Recruiting NCT05575167 - Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)
Recruiting NCT06164795 - Sequential Therapies After Osteoanabolic Treatment