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

Hospital Regional 1o de Octubre

Status: Completed

Conditions: Postmenopausal Osteoporosis; Hyperparathyroidism; Hypovitaminosis D

Treatments: Drug: Vitamin D; Drug: Risedronate

Study type: Interventional

Funder types: Other

Identifiers

NCT05346419

118.2021

Details and patient eligibility

About

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.

Full description

Participants were selected from the climacteric clinic of the regional hospital "1ro de Octubre-Instituto de Seguridad y Servicios Sociales para Los Trabajadores del Estado (ISSSTE)", Mexico. All participants voluntarily accepted to be part of the study and provided written informed consent.This study was approved by the institutional ethical committee of the hospital with registration number COFEPRIS 17 CI 09005135 with the internal registration number 118.2021. Every participant was clinically examined. Their metabolic state was assessed by considering height, weight, body mass index (BMI) and the percentage of Hb1Ac.

33 patients were included among 40 to 78 years with the diagnosis of postmenopausal osteoporosis with associated hyperparathyroidism, hypovitaminosis D or both conditions. All the patients were treated for 6 months with 35 mg of risedronate and 2800 IU of vitamin D once a week, with additional daily supplementation of 4000 IU of vitamin D.

Statical analysis was performed using PAST 3.0 and GraphPad Prism 8.4.3. software. Some statical parameters, such as arithmetic median (µ), and standard deviation (S.D.) were calculated using Excel-Word. Graphics were constructed with GraphPad Prism 8.4.3 and tables were done in Excel-Word. The assigned α value for this study was <0.05.

Enrollment: 33 patients

Sex: Female

Ages: 40 to 78 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Postmenopausal Osteopenia-osteoporosis patients

Experimental group

Description:

All participants were treated for 6 months with risedronate 35 mg and vitamin D 2800 IU once a week, with additional daily vitamin D supplementation of 4000 IU.

Treatment:

Drug: Risedronate

Drug: Vitamin D