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

Postmenopausal Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05346419
• Other study ID #: 118.2021
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: February 26, 2022

Study information

• Verified date: April 2022
• Source: Hospital Regional 1o de Octubre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 26, 2022
• Est. primary completion date: February 3, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 78 Years

Eligibility

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.

Related Conditions & MeSH terms

• Avitaminosis
• Hyperparathyroidism
• Hypovitaminosis D
• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis
• Rickets
• Vitamin D Deficiency

Intervention

Drug:
• Risedronate
Participants received risedronate 35 mg once a week for 6 months.
• Vitamin D
Participants received 2,800 IU of vitamin D once a week, with additional daily supplementation of 4,000 IU of vitamin D

Locations

Country	Name	City	State
Mexico	Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE	Mexico City

Sponsors (3)

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

Country where clinical trial is conducted

Mexico, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission of hyperparathyroidism	Remission of hyperparathyroidism was considered when serum parathyroid hormone [PTH] values were below 45 pg/mL.	6 months
Primary	Remission of hypovitaminosis D	Remission of hypovitaminosis D was considered when serum 25-hydroxy vitamin D [25(OH)D] was above 29 pg/ml.	6 months
Primary	Remission of osteopenia	Osteopenia remission was considered when densitometry T-score values were below -1.	6 months
Primary	Remission of Osteoporosis	Osteoporosis remission was considered when densitometry T-score values were below -2.4.	6 months
Secondary	Change from baseline serum calcium at 6 months	Calcium was evaluated as a bone mineralization marker.	6 months
Secondary	Change from baseline serum phosphorus at 6 months	Phosphorus was evaluated as a bone mineralization marker.	6 months
Secondary	Change from baseline urinary calcium at 6 months	Urinary calcium was evaluated as an indirect marker of bone demineralization.	6 months
Secondary	Change from bone resorption biomarker at 6 months	Alkaline Phosphatase was evaluated as a bone resorption biomarker.	6 months
Secondary	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.	6 months
Secondary	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.	6 months