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OpenTrials
Completed

NCT Number: NCT05346419

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

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.

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Key information

Conditions

Postmenopausal Osteoporosis Avitaminosis Bone Diseases Bone Diseases, Metabolic Bone Resorption Deficiency Diseases Endocrine System Diseases Hyperparathyroidism Hypovitaminosis D Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal Parathyroid Diseases Vitamin D Deficiency

Age range

40 year–78 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE

Mexico City, 07300, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

risedronate

Drug

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

Other names: SERALIS®

Vitamin D

Drug

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

Primary outcomes

  1. Remission of hyperparathyroidism

    Time frame: 6 months

    Remission of hyperparathyroidism was considered when serum parathyroid hormone [PTH] values were below 45 pg/mL.

  2. Remission of hypovitaminosis D

    Time frame: 6 months

    Remission of hypovitaminosis D was considered when serum 25-hydroxy vitamin D [25(OH)D] was above 29 pg/ml.

  3. Remission of osteopenia

    Time frame: 6 months

    Osteopenia remission was considered when densitometry T-score values were below -1.

  4. Remission of Osteoporosis

    Time frame: 6 months

    Osteoporosis remission was considered when densitometry T-score values were below -2.4.

Secondary outcomes

  1. Change from baseline serum calcium at 6 months

    Time frame: 6 months

    Calcium was evaluated as a bone mineralization marker.

  2. Change from baseline serum phosphorus at 6 months

    Time frame: 6 months

    Phosphorus was evaluated as a bone mineralization marker.

  3. Change from baseline urinary calcium at 6 months

    Time frame: 6 months

    Urinary calcium was evaluated as an indirect marker of bone demineralization.

  4. Change from bone resorption biomarker at 6 months

    Time frame: 6 months

    Alkaline Phosphatase was evaluated as a bone resorption biomarker.

  5. Fracture Risk Assessment Tool (FRAX®) for hip fracture

    Time frame: 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.

  6. Fracture Risk Assessment Tool for major osteoporotic fracture (FRAX® Mo)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital Regional 1o de Octubre

Other

Collaborators

  • National Polytechnic Institute, Mexico
  • Universidad Nacional Autonoma de Mexico

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 26, 2022
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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