NCT05346419

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Hospital Regional 1o de Octubre · Academic / Other
• Sex: Female
• Age: 40 Years – 78 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Postmenopausal Osteoporosis
• Hypovitaminosis D
• Hyperparathyroidism

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-02-03
• Completion: 2022-02-26
• First posted: 2022-04-26
• Last updated: 2022-04-26

Locations

1 site across 1 country: Mexico