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

• Status: Completed
• Trial end date: 2022-02-26
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Regional 1o de Octubre
• Collaborators: National Polytechnic Institute, Mexico; Universidad Nacional Autonoma de Mexico
• Treatments: Risedronic Acid; Vitamin D

Criteria

Inclusion Criteria:

• Participants with a diagnosis of postmenopausal osteoporosis or osteopenia.

• Participants with a diagnosis of hyperparathyroidism or hypovitaminosis D.

• Participants who accepted to participate and that provided informed consent.

Exclusion Criteria:

• Participants with oncological pathologies.

• Participants with recent fractures.

• Participants with gastric intolerance or hypersensitivity to the drugs.

• Participants were under treatment with another antiresorptive or bone-forming drug, or if they were receiving treatment with thiazide diuretics, lithium, teriparatide or glucocorticoids.

• Participants with Addison's disease, pheochromocytoma or depressive disorders.