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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)

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-012-03
Enrollment
33
Registered
2003-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

None listed

Interventions

Alendronate 70 mg Type of group
Alendronate 70 mg will be administered once a week for 12 months. Group name:Risedronate 35 mg Type of group
Risedronate 35 mg once a week for 12 months will be administered.

Sponsors

MERCK SHARP & DOHME PERU S.R.L.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Outcome name:bone mineral density Measure:Average percentage change of baseline in bone mineral density in the hip trochanter at 12 months of treatment with 70 mg alendronate once a week compared to treatment with risedronate 35 mg once a week in postmenopausal women with osteoporosis. Timepoints:12 weeks—

Secondary

MeasureTime frame
Outcome name:serum BSAP, CTx, PINP and urinary NTx Measure:The average percentage change of the baseline in biochemical markers of bone recovery (serum BSAP, CTx, PINP and urinary NTx) at 3, 6 and 12 months of treatment with 70 mg of alendronate once a week compared to treatment with 35 mg of risedronate once a week. Timepoints:3, 6 and 12 months—

Countries

Peru

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results

None listed

Source: REPEC (via WHO ICTRP)