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

Not Applicable

Completed

• Conditions: Postmenopausal Osteoporosis; Hypovitaminosis D; Hyperparathyroidism
• Interventions: Drug: Risedronate; Drug: Vitamin D

• Registration Number: NCT05346419
• Lead Sponsor: Hospital Regional 1o de Octubre

Brief 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.

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2022-02-03
• Study Completion: 2022-02-26
• Status Verified: 2022-04
• Study First Submitted: 2022-04-15
• Study First Submitted QC: 2022-04-20
• Last Update Submitted: 2022-04-20
• Study First Posted: 2022-04-26
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Postmenopausal Osteopenia-osteoporosis patients	Risedronate	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.
Postmenopausal Osteopenia-osteoporosis patients	Vitamin D	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.

Primary Outcome Measures

Name	Time	Method
Remission of hyperparathyroidism	6 months	Remission of hyperparathyroidism was considered when serum parathyroid hormone \[PTH\] values were below 45 pg/mL.
Remission of hypovitaminosis D	6 months	Remission of hypovitaminosis D was considered when serum 25-hydroxy vitamin D \[25(OH)D\] was above 29 pg/ml.
Remission of osteopenia	6 months	Osteopenia remission was considered when densitometry T-score values were below -1.
Remission of Osteoporosis	6 months	Osteoporosis remission was considered when densitometry T-score values were below -2.4.

Secondary Outcome Measures

Name	Time	Method
Change from baseline serum calcium at 6 months	6 months	Calcium was evaluated as a bone mineralization marker.
Change from baseline serum phosphorus at 6 months	6 months	Phosphorus was evaluated as a bone mineralization marker.
Change from baseline urinary calcium at 6 months	6 months	Urinary calcium was evaluated as an indirect marker of bone demineralization.
Change from bone resorption biomarker at 6 months	6 months	Alkaline Phosphatase was evaluated as a bone resorption biomarker.
Fracture Risk Assessment Tool (FRAX®) for hip fracture	6 months	Fracture Risk Assessment Tool (FRAX®) for hip fracture was used to determine the 10-year probability of hip fracture. When the predicted risk was greater than 3% was considered a high risk for hip fracture, and when it was lower than 3%, it was considered a low risk for hip fracture.
Fracture Risk Assessment Tool for major osteoporotic fracture (FRAX® Mo)	6 months	Fracture Risk Assessment Tool for major osteoporotic fracture (FRAX® Mo) was used to determine the 10-year probability of major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). When the predicted risk was greater than 20% was considered a high risk for major osteoporotic fracture, and when it was lower than 20%, it was considered a low risk of major osteoporotic fracture.

Trial Locations

Locations (1)

Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE; 🇲🇽 Mexico City, Mexico