AN EXTENSION OF 12 MONTHS FOR: A RANDOMIZED, DOUBLE-BLIND, DOUBLE SIMULATOR, PARALLEL GROUP, MULTICENTRIC STUDY TO EVALUATE AND COMPARE THE EFFECTS OF ALENDRONATE AND RISEDRONATE ON BONE MINERAL DENSITY IN POSTMENUPAUSIC WOMEN WITH OSTEOPOROSIS (INTERNATIONAL FOSAMAX COMPARISON TESTS AND ACTONEL: FACT (BY ITS ACRONYMS IN ENGLISH) -INTERNATIONAL)
- Conditions
- -M810M810
- Registration Number
- PER-012-03
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
The participant is a patient of external consultation, who resides in the community,>
40 years (> 25 if it is menopausal due to a surgical procedure) and postmenopausal for at least 6 months, who have osteoporosis.
The patient is in good health according to her medical history, physical examination and laboratory selection evaluation, which allows her to complete the test without serious co-morbid events.
a. The patient is mentally or legally incapacitated or otherwise unable
to give informed consent.
b. The patient is a pregnant woman or who is breastfeeding or a woman in
potentially fertile.
c. The patient has participated in another therapeutic trial with a compound in investigation within 30 days prior to randomization.
d. The patient intends to move during the next year making the
follow-up is impractical.
e. The patient has a history of hypersensitivity to any component of
Alendronate tablets or risedronate tablets.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method