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Antiresorptive Effect of Treatment With Risedronate and Vitamin D in Postmenopausal Patients

NCT05346419 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-04-26

No results posted yet for this study

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.

Conditions

  • Postmenopausal Osteoporosis
  • Hypovitaminosis D
  • Hyperparathyroidism

Interventions

DRUG

Risedronate

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

DRUG

Vitamin D

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

Sponsors & Collaborators

  • National Polytechnic Institute, Mexico

    collaborator OTHER

  • Universidad Nacional Autonoma de Mexico

    collaborator OTHER

  • Hospital Regional 1o de Octubre

    lead OTHER

Principal Investigators

  • Juan M Ocampo Godínez, M.D., Ph.D. · Tissue Bioengineering Laboratory, National Autonomous University of Mexico [UNAM]

  • Patricia Loranca-Moreno, M.D., M.Sc. · Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.

  • Merle Y Hernández-Castañón, M.D. · Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
78 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-02-03
Completion
2022-02-26

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05346419 on ClinicalTrials.gov