Antiresorptive Effect of Treatment With Risedronate and Vitamin D in Postmenopausal Patients
Primary Purpose
Postmenopausal Osteoporosis, Hypovitaminosis D, Hyperparathyroidism
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Risedronate
Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Postmenopause, Postmenopausal Osteoporosis, Hypovitaminosis D, Hyperparathyroidism, Risedronate, Osteopenia, Bone Mineral Density, Bone resorption
Eligibility 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.
Sites / Locations
- Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Postmenopausal Osteopenia-osteoporosis patients
Arm 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.
Outcomes
Primary Outcome Measures
Remission of hyperparathyroidism
Remission of hyperparathyroidism was considered when serum parathyroid hormone [PTH] values were below 45 pg/mL.
Remission of hypovitaminosis D
Remission of hypovitaminosis D was considered when serum 25-hydroxy vitamin D [25(OH)D] was above 29 pg/ml.
Remission of osteopenia
Osteopenia remission was considered when densitometry T-score values were below -1.
Remission of Osteoporosis
Osteoporosis remission was considered when densitometry T-score values were below -2.4.
Secondary Outcome Measures
Change from baseline serum calcium at 6 months
Calcium was evaluated as a bone mineralization marker.
Change from baseline serum phosphorus at 6 months
Phosphorus was evaluated as a bone mineralization marker.
Change from baseline urinary calcium at 6 months
Urinary calcium was evaluated as an indirect marker of bone demineralization.
Change from bone resorption biomarker at 6 months
Alkaline Phosphatase was evaluated as a bone resorption biomarker.
Fracture Risk Assessment Tool (FRAX®) for hip fracture
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)
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.
Full Information
NCT ID
NCT05346419
First Posted
April 15, 2022
Last Updated
April 20, 2022
Sponsor
Hospital Regional 1o de Octubre
Collaborators
National Polytechnic Institute, Mexico, Universidad Nacional Autonoma de Mexico
1. Study Identification
Unique Protocol Identification Number
NCT05346419
Brief Title
Antiresorptive Effect of Treatment With Risedronate and Vitamin D in Postmenopausal Patients
Official Title
Risedronate With High-dose Vitamin D Resolves Hyperparathyroidism and Hypovitaminosis D But Not Osteoporosis in Mexican Postmenopausal Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
February 3, 2022 (Actual)
Study Completion Date
February 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Regional 1o de Octubre
Collaborators
National Polytechnic Institute, Mexico, Universidad Nacional Autonoma de Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis, Hypovitaminosis D, Hyperparathyroidism
Keywords
Postmenopause, Postmenopausal Osteoporosis, Hypovitaminosis D, Hyperparathyroidism, Risedronate, Osteopenia, Bone Mineral Density, Bone resorption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Postmenopausal Osteopenia-osteoporosis patients
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Risedronate
Other Intervention Name(s)
SERALIS®
Intervention Description
Participants received risedronate 35 mg once a week for 6 months.
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Generic
Intervention Description
Participants received 2,800 IU of vitamin D once a week, with additional daily supplementation of 4,000 IU of vitamin D
Primary Outcome Measure Information:
Title
Remission of hyperparathyroidism
Description
Remission of hyperparathyroidism was considered when serum parathyroid hormone [PTH] values were below 45 pg/mL.
Time Frame
6 months
Title
Remission of hypovitaminosis D
Description
Remission of hypovitaminosis D was considered when serum 25-hydroxy vitamin D [25(OH)D] was above 29 pg/ml.
Time Frame
6 months
Title
Remission of osteopenia
Description
Osteopenia remission was considered when densitometry T-score values were below -1.
Time Frame
6 months
Title
Remission of Osteoporosis
Description
Osteoporosis remission was considered when densitometry T-score values were below -2.4.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline serum calcium at 6 months
Description
Calcium was evaluated as a bone mineralization marker.
Time Frame
6 months
Title
Change from baseline serum phosphorus at 6 months
Description
Phosphorus was evaluated as a bone mineralization marker.
Time Frame
6 months
Title
Change from baseline urinary calcium at 6 months
Description
Urinary calcium was evaluated as an indirect marker of bone demineralization.
Time Frame
6 months
Title
Change from bone resorption biomarker at 6 months
Description
Alkaline Phosphatase was evaluated as a bone resorption biomarker.
Time Frame
6 months
Title
Fracture Risk Assessment Tool (FRAX®) for hip fracture
Description
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.
Time Frame
6 months
Title
Fracture Risk Assessment Tool for major osteoporotic fracture (FRAX® Mo)
Description
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.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan M Ocampo Godínez, M.D., Ph.D.
Organizational Affiliation
Tissue Bioengineering Laboratory, National Autonomous University of Mexico [UNAM]
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Patricia Loranca-Moreno, M.D., M.Sc.
Organizational Affiliation
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Merle Y Hernández-Castañón, M.D.
Organizational Affiliation
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE
City
Mexico City
ZIP/Postal Code
07300
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
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Antiresorptive Effect of Treatment With Risedronate and Vitamin D in Postmenopausal Patients
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