An interventional study of Risedronate and Vitamin D in Postmenopausal Osteoporosis, Hypovitaminosis D and Hyperparathyroidism, sponsored by Hospital Regional 1o de Octubre. Completed at 1 site in Mexico. Open to female participants aged 40 Years to 78 Years. Per ClinicalTrials.gov, last updated 2022-04-26.
Sponsored by Hospital Regional 1o de Octubre · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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 · Drug: Vitamin D
Participants received risedronate 35 mg once a week for 6 months.
Also known as: SERALIS®
Participants received 2,800 IU of vitamin D once a week, with additional daily supplementation of 4,000 IU of vitamin D
Also known as: Generic
Remission of hyperparathyroidism
Remission of hyperparathyroidism was considered when serum parathyroid hormone \[PTH\] values were below 45 pg/mL.
Time frame: 6 months
Remission of hypovitaminosis D
Remission of hypovitaminosis D was considered when serum 25-hydroxy vitamin D \[25(OH)D\] was above 29 pg/ml.
Time frame: 6 months
Remission of osteopenia
Osteopenia remission was considered when densitometry T-score values were below -1.
Time frame: 6 months
Remission of Osteoporosis
Osteoporosis remission was considered when densitometry T-score values were below -2.4.
Time frame: 6 months
Change from baseline serum calcium at 6 months
Calcium was evaluated as a bone mineralization marker.
Time frame: 6 months
Change from baseline serum phosphorus at 6 months
Phosphorus was evaluated as a bone mineralization marker.
Time frame: 6 months
Change from baseline urinary calcium at 6 months
Urinary calcium was evaluated as an indirect marker of bone demineralization.
Time frame: 6 months
Change from bone resorption biomarker at 6 months
Alkaline Phosphatase was evaluated as a bone resorption biomarker.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
Plan to share: No
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Hospital Regional 1o de Octubre