Postmenopausal OsteoporosisNCT06264401
Treatment Exercises With Core Stability and Dynamic Resistance Exercise for Postmenopausal Women With Osteoporosis
A study testing Alendronate and treatment exercises in people with Postmenopausal Osteoporosis, run by Cairo University at 1 site in Egypt.
Trial summary
osteoporosis is a common disease that affect most of postmenopausal women. various treatment procedures are used to avoid future complain among postmenopausal population. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Alendronate and treatment exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 2 Jun 2024
- 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 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Their ages were ranged from 50-60 years.
- Their BMI not exceeded 30 kg/m2.
- All postmenopausal women past of at least one year after menopause.
- Had no regular physical activities during the past 6 months.
Who cannot join
- Patients didn't take any drug before the study (e.g. calcium tablets, multivitamins containing calcium and vitamin D) that affects bone metabolism.
- Patients that were smoking or having alcohol consumption.
- Histories of fracture and surgery, or severe injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Exercises With Core Stability and Dynamic Resistance Exercise for Postmenopausal Women With Osteoporosis: A Randomized Controlled Trial
osteoporosis is a common disease that affect most of postmenopausal women. various treatment procedures are used to avoid future complain among postmenopausal population.
Read the detailed description
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.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Alendronate, treatment exercises
- Keywords
- postmenopausal, osteoporosis, corestability, dynamic resistance, bone mineral density
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlendronateOther
control group received (Alendronate) 70 mg 1 tab every week.
treatment exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| placepo group | Experimental | Alendronate:
the experimental and control group received (Alendronate) 70 mg 1 tab every week for 4 months. Receives: Other: Alendronate |
| exercises and alendronate group | Experimental | 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. Receives: Other: Alendronate; Other: treatment exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: period of treatment was 4 successive months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Feb 2024
- Primary completion30 May 2024
- Study completion2 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention: medication the experimental and control groups 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermeen Shaaban Abd El Azeim, Cairo University
- Investigators
- Hala Emara, phd, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264401
- Sponsor's protocol ID
- menopausal with osteoporsis
- Status last verified
- Jun 2024
- First submitted
- 9 Feb 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Exercises With Core Stability and Dynamic Resistance Exercise for Postmenopausal Women With Osteoporosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06264401
- Acronym / sponsor ID
- menopausal with osteoporsis
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- postmenopausal, osteoporosis, corestability, dynamic resistance, bone mineral density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 2 Jun 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
osteoporosis is a common disease that affect most of postmenopausal women. various treatment procedures are used to avoid future complain among postmenopausal population.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- intervention: medication the experimental and control groups 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.
| Arm | Type | Receives |
|---|---|---|
| placepo group | Experimental | Other: AlendronateAlendronate: the experimental and control group received (Alendronate) 70 mg 1 tab every week for 4 months. |
| exercises and alendronate group | Experimental | Other: Alendronate, Other: treatment exercisesalendronate: 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. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Their ages were ranged from 50-60 years.
- Their BMI not exceeded 30 kg/m2.
- All postmenopausal women past of at least one year after menopause.
- Had no regular physical activities during the past 6 months.
Key exclusion criteria (3 listed)
- Patients didn't take any drug before the study (e.g. calcium tablets, multivitamins containing calcium and vitamin D) that affects bone metabolism.
- Patients that were smoking or having alcohol consumption.
- Histories of fracture and surgery, or severe injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alendronatecontrol group received (Alendronate) 70 mg 1 tab every week. | Other | exercises and alendronate group, placepo group |
| treatment exercisesthe 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. | Other | exercises and alendronate group |
Primary outcome
Dual-energy x-ray absorptiometry
Time frame: period of treatment was 4 successive months.
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
Oswestry Disability Index
Time frame: period of treatment was 4 successive months.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hala Emara, phd study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alendronate and treatment exercises in people with Postmenopausal Osteoporosis, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 3 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 Jun 2024. 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 Egypt. 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?
Dual-energy x-ray absorptiometry (time frame: period of treatment was 4 successive months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2024.