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Postmenopausal OsteoporosisNCT05346419

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

A study testing Risedronate and Vitamin D in people with Postmenopausal Osteoporosis and Hypovitaminosis D, run by Hospital Regional 1o de Octubre at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 78 years, women only
What is being tested?
Risedronate and Vitamin D
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteMexico
Study dates
1 Jul 2021to 26 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 78 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

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

    Mexico City, 07300

Other trials in Mexico

About this study

Official title: Risedronate With High-dose Vitamin D Resolves Hyperparathyroidism and Hypovitaminosis D But Not Osteoporosis in Mexican 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.

Read the 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.

Being tested
Risedronate, Vitamin D
Keywords
Postmenopause, Postmenopausal Osteoporosis, Hypovitaminosis D, Hyperparathyroidism, Risedronate, Osteopenia, Bone Mineral Density, Bone resorption
Medical subject headings
Osteoporosis, Postmenopausal, Vitamin D Deficiency, Hyperparathyroidism, Bone Diseases, Metabolic, Bone Resorption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RisedronateDrug

    Also called SERALIS®

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

  • Vitamin DDrug

    Also called Generic

    Participants received 2,800 IU of vitamin D once a week, with additional daily supplementation of 4,000 IU of vitamin D

Study groups in NCT05346419
Study groupRoleWhat they receive
Postmenopausal Osteopenia-osteoporosis patientsExperimentalAll 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.
Receives: Drug: Risedronate; Drug: Vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Remission of hyperparathyroidism

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

    Measured: 6 months

  2. Remission of hypovitaminosis D

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

    Measured: 6 months

  3. Remission of osteopenia

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

    Measured: 6 months

  4. Remission of Osteoporosis

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

    Measured: 6 months

Secondary outcomes (6)

  1. Change from baseline serum calcium at 6 months

    Calcium was evaluated as a bone mineralization marker.

    Measured: 6 months

  2. Change from baseline serum phosphorus at 6 months

    Phosphorus was evaluated as a bone mineralization marker.

    Measured: 6 months

  3. Change from baseline urinary calcium at 6 months

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

    Measured: 6 months

  4. Change from bone resorption biomarker at 6 months

    Alkaline Phosphatase was evaluated as a bone resorption biomarker.

    Measured: 6 months

  5. 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.

    Measured: 6 months

  6. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2022
  2. Study start1 Jul 2021
  3. Primary completion3 Feb 2022
  4. Study completion26 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05346419
Sponsor's protocol ID
118.2021
Status last verified
Apr 2022
First submitted
15 Apr 2022
Last updated
26 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cossio-Bolanos M, Vidal-Espinoza R, Fuentes-Lopez J, Castelli Correia de Campos LF, Andruske CL, Urra-Albornoz C, Alvear Vasquez F, Gomez-Campos R. Reference values for bone density and bone mineral content from 5 to 80 years old in a province of Chile. PeerJ. 2022 Mar 23;10:e13092. doi: 10.7717/peerj.13092. eCollection 2022.

    PubMed 35345584

  • Kanis JA, Cooper C, Rizzoli R, Reginster JY; Scientific Advisory Board of the European Society for Clinical and Economic Aspects of Osteoporosis (ESCEO) and the Committees of Scientific Advisors and National Societies of the International Osteoporosis Foundation (IOF). European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. 2019 Jan;30(1):3-44. doi: 10.1007/s00198-018-4704-5. Epub 2018 Oct 15.

    PubMed 30324412

  • Deng W, Han JC, Chen L, Qi WL. Estrogen receptor alpha gene PvuII polymorphism and risk of fracture in postmenopausal women: a meta-analysis. Genet Mol Res. 2015 Feb 13;14(1):1293-300. doi: 10.4238/2015.February.13.8.

    PubMed 25730068

  • Aziziyeh R, Amin M, Habib M, Perlaza JG, McTavish RK, Ludke A, Fernandes S, Sripada K, Cameron C. A scorecard for osteoporosis in four Latin American countries: Brazil, Mexico, Colombia, and Argentina. Arch Osteoporos. 2019 Jun 27;14(1):69. doi: 10.1007/s11657-019-0622-1.

    PubMed 31250192

  • Moschonis G, van den Heuvel EG, Mavrogianni C, Manios Y. Effect of Vitamin D-Enriched Gouda-Type Cheese Consumption on Biochemical Markers of Bone Metabolism in Postmenopausal Women in Greece. Nutrients. 2021 Aug 27;13(9):2985. doi: 10.3390/nu13092985.

    PubMed 34578863

  • Bouloukaki I, Markakis M, Pateli R, Lyronis I, Schiza S, Tsiligianni I. Vitamin D levels in primary care patients: correlations with clinical, seasonal, and quality-of-life parameters. Fam Pract. 2022 Jul 19;39(4):678-684. doi: 10.1093/fampra/cmac012.

    PubMed 35325110

  • Dixit V, Tripathi RL, Dhanwal DK. Lack of secondary hyperparathyroidism in sub-group of vitamin D deficient postmenopausal women: Is VDR gene polymorphism behind this mystery? Diabetes Metab Syndr. 2022 Jan;16(1):102381. doi: 10.1016/j.dsx.2021.102381. Epub 2021 Dec 28.

    PubMed 34995987

  • Lips P, Hosking D, Lippuner K, Norquist JM, Wehren L, Maalouf G, Ragi-Eis S, Chandler J. The prevalence of vitamin D inadequacy amongst women with osteoporosis: an international epidemiological investigation. J Intern Med. 2006 Sep;260(3):245-54. doi: 10.1111/j.1365-2796.2006.01685.x.

    PubMed 16918822

  • Martinez-Zavala N, Lopez-Sanchez GN, Vergara-Lopez A, Chavez-Tapia NC, Uribe M, Nuno-Lambarri N. Vitamin D deficiency in Mexicans have a high prevalence: a cross-sectional analysis of the patients from the Centro Medico Nacional 20 de Noviembre. Arch Osteoporos. 2020 Jun 16;15(1):88. doi: 10.1007/s11657-020-00765-w.

    PubMed 32542548

  • Wihlborg A, Bergstrom K, Gerdhem P, Bergstrom I. Parathyroid Hormone Disturbances in Postmenopausal Women with Distal Forearm Fracture. World J Surg. 2022 Jan;46(1):128-135. doi: 10.1007/s00268-021-06331-w. Epub 2021 Oct 13.

    PubMed 34647149

  • Yalla N, Bobba G, Guo G, Stankiewicz A, Ostlund R. Parathyroid hormone reference ranges in healthy individuals classified by vitamin D status. J Endocrinol Invest. 2019 Nov;42(11):1353-1360. doi: 10.1007/s40618-019-01075-w. Epub 2019 Jul 4.

    PubMed 31273631

  • Clark P, Vivanco-Munoz N, Pina JT, Rivas-Ruiz R, Huitron G, Chico-Barba G, Reza-Albarran AA. High prevalence of hypovitaminosis D in Mexicans aged 14 years and older and its correlation with parathyroid hormone. Arch Osteoporos. 2015;10:225. doi: 10.1007/s11657-015-0225-4. Epub 2015 Jul 14.

    PubMed 26168767

  • Yuan F, Peng W, Yang C, Zheng J. Teriparatide versus bisphosphonates for treatment of postmenopausal osteoporosis: A meta-analysis. Int J Surg. 2019 Jun;66:1-11. doi: 10.1016/j.ijsu.2019.03.004. Epub 2019 Mar 16.

    PubMed 30890377

  • Miller PD, Hattersley G, Riis BJ, Williams GC, Lau E, Russo LA, Alexandersen P, Zerbini CA, Hu MY, Harris AG, Fitzpatrick LA, Cosman F, Christiansen C; ACTIVE Study Investigators. Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial. JAMA. 2016 Aug 16;316(7):722-33. doi: 10.1001/jama.2016.11136.

    PubMed 27533157

  • Soreskog E, Lindberg I, Kanis JA, Akesson KE, Willems D, Lorentzon M, Strom O, Berling P, Borgstrom F. Cost-effectiveness of romosozumab for the treatment of postmenopausal women with severe osteoporosis at high risk of fracture in Sweden. Osteoporos Int. 2021 Mar;32(3):585-594. doi: 10.1007/s00198-020-05780-8. Epub 2021 Jan 6.

    PubMed 33409591

Questions about this trial

What is this clinical trial studying?

A study testing Risedronate and Vitamin D in people with Postmenopausal Osteoporosis and Hypovitaminosis D, run by Hospital Regional 1o de Octubre at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Remission of hyperparathyroidism (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05346419, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.

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