Antiresorptive Effect of Treatment With Risedronate and Vitamin D in Postmenopausal Patients
Condition: Postmenopausal Osteoporosis; Hypovitaminosis D; Hyperparathyroidism
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Rickets; Avitaminosis; Vitamin D Deficiency; Hyperparathyroidism
Study type: Interventional

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.
    

Intervention name(s): Risedronate; Vitamin D
Intervention type(s): Drug; Drug
Intervention description(s): Participants received risedronate 35 mg once a week for 6 months.; Participants received 2,800 IU of vitamin D once a week, with additional daily supplementation of 4,000 IU of vitamin D
Other intervention name(s): SERALIS®; Generic
Intervention MeSH terms: Vitamin D; Risedronic Acid
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postmenopause; Postmenopausal Osteoporosis; Hypovitaminosis D; Hyperparathyroidism; Risedronate; Osteopenia; Bone Mineral Density; Bone resorption