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

Sponsor

Hospital Regional 1o de Octubre (Other)

Overall Status

Completed

CT.gov ID

NCT05346419

Collaborator

National Polytechnic Institute, Mexico (Other), Universidad Nacional Autonoma de Mexico (Other)

Enrollment

Location

Arm

7.9

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Osteoporosis Hypovitaminosis D Hyperparathyroidism	Drug: Risedronate Drug: Vitamin D	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

33 participants between 40 and 78 years old with a diagnosis of postmenopausal osteoporosis or osteopenia with associated hyperparathyroidism, hypovitaminosis or both conditions were selected. 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.33 participants between 40 and 78 years old with a diagnosis of postmenopausal osteoporosis or osteopenia with associated hyperparathyroidism, hypovitaminosis or both conditions were selected. 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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2021

Actual Primary Completion Date :

Feb 3, 2022

Actual Study Completion Date :

Feb 26, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Postmenopausal Osteopenia-osteoporosis patients 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.	Drug: Risedronate Participants received risedronate 35 mg once a week for 6 months. Other Names: SERALIS® 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 Other Names: Generic

Arm

Intervention/Treatment

Experimental: Postmenopausal Osteopenia-osteoporosis patients

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.

Drug: Risedronate

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

Other Names:

SERALIS®

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

Other Names:

Generic

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 78 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE	Mexico City		Mexico	07300

Sponsors and Collaborators

Hospital Regional 1o de Octubre
National Polytechnic Institute, Mexico
Universidad Nacional Autonoma de Mexico

Investigators

Study Director: Juan M Ocampo Godínez, M.D., Ph.D., Tissue Bioengineering Laboratory, National Autonomous University of Mexico [UNAM]
Study Director: Patricia Loranca-Moreno, M.D., M.Sc., Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.
Principal Investigator: Merle Y Hernández-Castañón, M.D., Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE