An interventional study of Alendronate and treatment exercises in Postmenopausal Osteoporosis, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 50 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-26.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
osteoporosis is a common disease that affect most of postmenopausal women. various treatment procedures are used to avoid future complain among postmenopausal population.
Ethics statement This study was approved by the institutional review board of the faculty of physical therapy, Cairo university, Egypt (no.P.T. REC/012/003867) and strictly adhered to the criteria proclaimed in the latest version of the declaration of Helsinki code of ethics. each woman freely consents to participate in this research study.
study design. A prospective double-masked randomized controlled trial.
sample size calculation. Based on a pilot study, sample size was calculated according to the significant difference in the value of mean difference (pretreatments - posttreatment values) of ODI between control (16.60 ± 2.22) and study (26.50 ± 4.09) groups in two tailed unpaired t test, with α=0.05, power of 80%, and an effect size of 0.74. So, a sample size of 30 patients/per group would be required and increased to 35 women to allow for a 15% dropout rate (Power 301 http: www.psycho.uni-duesseldorf.de) Randomization. Randomization of sample selection were achieved using closed envelop way to allocate study participants to either intervention group (medication and treatment exercises) control group (medication only). all postmenopausal women and examiners were unaware of group allocation.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 60 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Alendronate: the experimental and control group received (Alendronate) 70 mg 1 tab every week for 4 months.
Other: Alendronate
alendronate: the experimental and control group received (Alendronate) 70 mg 1 tab every week for 4 months. treatment exercises: the experimental group performed core stability and dynamic resistance exercises, a 45-min lumbar-pelvic/core strength and stability exercise program which include 5 min warming up and 5 min cooling down at the end of the session each exercise was executed for three sets of 15 seconds, which gradually upgraded to three sets of 45-second at the fourth month and 10 sec rest between each set and dynamic resistance exercise performed by each woman for 2 sets for 8-12 repetitions gradually along the study of 90 sec rest between each set for a duration of 60 min including 10 min warming up and 10 min cooling down in form of stretching.
Other: Alendronate · Other: treatment exercises
control group received (Alendronate) 70 mg 1 tab every week.
the experimental group performed core stability and dynamic resistance exercises, a 45-min lumbar-pelvic/core strength and stability exercise program, each exercise was executed for three sets of 15 seconds, which gradually upgraded to three sets of 45-second at the fourth month and 10 sec rest between each set and dynamic resistance exercise performed by each woman for 2 sets for 8-12 repetitions gradually along the study of 90 sec rest between each set for a duration of 60 minutes.
Dual-energy x-ray absorptiometry
a valid and reliable method for assessing bone mineral density, A normal T score is -1.0 and above, low bone density is between -1.0 and -2.5, and osteoporosis is -2.5 and lower
Time frame: period of treatment was 4 successive months.
Oswestry Disability Index
reliable method for assessing quality of life, The 10 factors which constitute the ODI criteria for assessing patients' functional impairment are pain intensity, ease of personal care, lifting, working, sitting, standing, sleeping, sex life, social life and travelling. Each of the 10 questions is scored from 0 to 5, giving a maximum score of 50. The total score is then converted into a percentage by multiplying it by 2.
Time frame: period of treatment was 4 successive months.
Plan to share: No
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Cairo University