CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 33 enrolled
Drug / intervention
Risedronate +1 moredrug
Likely dose
Risedronate 35 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05346419
NCT05346419N/ACompleted

Risedronate With High-dose Vitamin D Resolves Hyperparathyroidism and Hypovitaminosis D But Not Osteoporosis in Mexican Postmenopausal Patients

Hospital Regional 1o de Octubre·interventional·Posted Apr 26, 2022·Updated Apr 26, 2022

In Brief

A clinical study evaluating Risedronate and Vitamin D for Postmenopausal Osteoporosis and 2 related conditions. Completed, enrolled 33 participants across 1 site.

Detailed Summary

Osteoporosis is defined as a systemic disease of bone mineralization, characterized by a decrease in bone mineral density that causes bone fragility and increases the risk of fractures during menopause. Recently, a high prevalence of hypovitaminosis D has been found worldwide, which could trigger a state of secondary hyperparathyroidism that can worsen the state of postmenopausal patients with osteoporosis. An open-label, clinical trial was conducted in Mexican women with postmenopausal osteopenia-osteoporosis to determine the efficacy of the combined treatment with risedronate and high-dose vitamin D in improving bone mineral density, hyperparathyroidism, and hypovitaminosis D.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 26, 2022
Enrollment StartJul 1, 2021
Primary CompletionFeb 3, 2022
Study CompletionFeb 26, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.2 years ago

Interventions

Risedronatedrug

Participants received risedronate 35 mg once a week for 6 months.

Vitamin Ddrug

Participants received 2,800 IU of vitamin D once a week, with additional daily supplementation of 4,000 IU of vitamin D