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

NCT05346419 | Completed DMC

• 1 other identifier: 118.2021
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Osteoporosis; Hypovitaminosis D; Hyperparathyroidism

Keywords

Postmenopause; Postmenopausal Osteoporosis; Hypovitaminosis D; Hyperparathyroidism; Risedronate; Osteopenia; Bone Mineral Density; Bone resorption

Outcome Measures

Primary Outcomes (4)

• Remission of hyperparathyroidism

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

  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.

  6 months

• Remission of osteopenia

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

  6 months

• Remission of Osteoporosis

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

  6 months

Secondary Outcomes (6)

• Change from baseline serum calcium at 6 months

  6 months

• Change from baseline serum phosphorus at 6 months

  6 months

• Change from baseline urinary calcium at 6 months

  6 months

• Change from bone resorption biomarker at 6 months

  6 months

• Fracture Risk Assessment Tool (FRAX®) for hip fracture

  6 months

Study Arms (1)

Postmenopausal Osteopenia-osteoporosis patients

EXPERIMENTAL

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

Interventions

Risedronate DRUG

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

Also known as: SERALIS®

Postmenopausal Osteopenia-osteoporosis patients

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

Also known as: Generic

Postmenopausal Osteopenia-osteoporosis patients

Eligibility Criteria

• Age: 40 Years - 78 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Regional 1o de Octubre: lead
• National Polytechnic Institute, Mexico: collaborator
• Universidad Nacional Autonoma de Mexico: collaborator

Study Sites (1)

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

Mexico City, 07300, Mexico

Location

Related Publications (31)

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MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Vitamin D Deficiency; Hyperparathyroidism; Bone Diseases, Metabolic; Bone Resorption

Interventions

Risedronic Acid; Vitamin D; Drugs, Generic

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pharmaceutical Preparations

Study Officials

• Juan M Ocampo Godínez, M.D., Ph.D.

  Tissue Bioengineering Laboratory, National Autonomous University of Mexico [UNAM]

  STUDY DIRECTOR

• Patricia Loranca-Moreno, M.D., M.Sc.

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

  STUDY DIRECTOR

• Merle Y Hernández-Castañón, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 26, 2022
• Study Start: July 1, 2021
• Primary Completion: February 3, 2022
• Study Completion: February 26, 2022
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)