An interventional study of Physical exercise + Vitamin D3 and Physical exercise in Osteoporosis, Osteopenia and Osteoporosis, Postmenopausal, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to female participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-04-24.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
Among 11 studies in Osteoporosis, Postmenopausal with a site in Brazil — none open to participants now, none under way, none of them phase 3. Osteoporosis, Postmenopausal · Brazil.
Among the 11 studies in Osteoporosis, Postmenopausal with a site in Brazil, this one is the 11th largest by enrollment, is the only one that started in 2018, is the only one with no phase, and was the 11th registered.
334 studies on the registry are indexed under Osteoporosis, Postmenopausal; 28 are open to participants now.
Browse Osteoporosis, Postmenopausal studies →None of the 11 studies in Osteoporosis, Postmenopausal with a site in Brazil is open now.
Of the 19 Osteoporosis, Postmenopausal studies recruiting now, 8 (42%) set no upper age limit and 7 (37%) stop at 75 or younger; 1 take children under 18; 7 take healthy volunteers.
This study: 60 Years to 75 Years · female · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2018.
This study's enrollment of 46 is below the median of 119 across 264 interventional studies indexed under Osteoporosis, Postmenopausal.
Median enrollment 1,294 across the 11 interventional studies. Of the 11 that completed or were terminated, 10 (91%) have results posted.
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10 of 11 have an industry lead sponsor. The 6 most frequent:
University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
University of Sao Paulo General Hospital has 1 study filed under Osteoporosis, Postmenopausal — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Osteoporosis, Postmenopausal with a site in Brazil, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Introduction: In Brazil, a person who is sixty years old or more is considered elderly. The incidence of osteoporosis and osteopenia has been increasing, as have fractures resulting from falls. Vitamin D deficiency can cause muscular atrophy in type II fibers (fast contraction and strength), which can increase the risk of falls. The aging process produces reduction in the ability of postural control system to maintain postural balance, which may increase postural instability and consequently increase the elderly risk to falls. Objective: To evaluate if vitamin D supplementation associated with regular exercise in vulnerable older women improves muscle strength and postural balance in 12 weeks. Methods: This will be a randomized prospective clinical trial, double blind, placebo-controlled intervention. Will be part of the study 40 elderly women vulnerable, who meet the inclusion criteria and that will be coming from the community through calls made by radio and social network. The volunteer will undergoing to blood test, body composition and bone mineral density, Mini Mental State Examination, Geriatric Depressive Scale, Falls Efficacy Scale, WHOQOL-OLD and WHOQOL-BREF instruments, functional capacity tests (MiniBEST, Time up and Go, Chair Rising Test, Six-minute walk test), muscular strength assessment (isokinetic dynamometry, handgrip and 1RM test) and postural balance (AccSway force platform for static postural balance and NeuroCom's Balance Master for dynamic postural balance) before and after 12 weeks of intervention with vitamin D supplementation and resistance and postural balance exercise. The intervention that will be perform during the 12 weeks with a progressive resistance training program.
334 studies on the registry are indexed under Osteoporosis, Postmenopausal; 28 are open to participants now.
This study's enrollment of 46 is below the median of 119 across 264 interventional studies indexed under Osteoporosis, Postmenopausal.
Browse Osteoporosis, Postmenopausal studies →University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Osteoporosis, Postmenopausal, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Osteoporosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria:
The experimental group, which will supplement vitamin D3 50,000 IU / week, being in two capsules (25,000 IU / week each),
Dietary Supplement: Physical exercise + Vitamin D3
The placebo group will inject two capsules of equal size, volume and coloration, composed of lactose, without the vitamin D3 supplement.
Other: Physical exercise
Strength exercise + Supplementation of vitamin D3 50,000 IU / week
Strength exercise
Postural balance - semi static - change
Evaluation of postural balance - AccSway force platform for semi static postural. The arithmetic mean of the results was calculated from the three tests conducted under each condition, and was processed using the Balance Clinic software. The following parameters were used to measure the stability of the participants: medial-lateral and anteroposterior amplitude (cm), the mean velocity calculated from the total displacement of the center of pressure (COP) in all directions (cm/s), and the elliptical area encompassing 95% of the displacement from the COP (cm2). The following parameters were used to measure the stability of the participants: medial-lateral and anteroposterior amplitude (cm), the mean velocity calculated from the total displacement of the center of pressure (COP) in all directions (cm/s).
Time frame: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
Postural balance - dynamic - change
Evaluation of dynamic postural balance - The postural balance assessment (posturography) will be perform on the NeuroCom Balance Master® force platform system (NeuroCom International, Inc., Clackamas, OR, USA). The variables will be the mean sway speed (cm/s) on a stable surface and an unstable surface; and the mean sway in the anteropoterior direction and mediolateral (cm) direction at the same conditions. The variables will be the mean weight transfer index (%), mean movement time (s) and mean impact index.
Time frame: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
Muscular strength - Hand Grip - change
Evaluation of muscular strength improvement- hand grip strength (HGS). HGS assessment was performed using a Jamar hand dynamometer, measured in kilograms (kg), which is adopted by the American Society of Hand Therapists (ASHT).
Time frame: This measure will be perform before and after the intervation (12 weeks strenght and potural balance exercise).
Muscular strength - Isokinetic dynamometry - change
Evaluation of muscular strength improvement - Isokinetic dynamometry will be use to determine knee extension and flexion strength using the Biodex Multi-Joint System 3 (Biodex MedicalTM, Shirley, NY, USA). The isokinetic variables used were maximum peak torque corrected for body weight (%), and total work (J).
Time frame: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
Muscular strength - 1 maximal repetition (RM)- change
Evaluation of muscular strength improvement - 1RM test. One-repetition maximum in weight training is the maximum amount of force that can be generated in one maximal contraction (kg).
Time frame: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
Body composition and bone mineral density - change
Evaluation of body composition (area=cm2; BMC=g and BMD=g/cm2) and bone mineral density (BMD=g/cm2; T-score)
Time frame: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Dec 2018, 10 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 10 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 Oct 2019. You cannot join it, but the record below documents what was studied.
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Osteoporosis, Postmenopausal →
University of Sao Paulo General Hospital →