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.
334 studies on the registry are indexed under Osteoporosis, Postmenopausal; 28 are open to participants now.
This study's enrollment of 33 is below the median of 119 across 264 interventional studies indexed under Osteoporosis, Postmenopausal.
Browse Osteoporosis, Postmenopausal studies →Hospital Regional 1o de Octubre is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Jul 2021 to primary completion in Feb 2022, 7 months.
Of 47 non-industry interventional studies with no phase under Osteoporosis, Postmenopausal, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's 7 months is below that.
Counting every sponsor, half of 50 studies reached it within 17 months; a quarter within 9 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Risedronic Acid · Vitamin D
Osteoporosis, Postmenopausal →
Hospital Regional 1o de Octubre