NCT06264401

Brief Summary

osteoporosis is a common disease that affect most of postmenopausal women. various treatment procedures are used to avoid future complain among postmenopausal population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

February 9, 2024

Last Update Submit

June 25, 2024

Conditions

Keywords

postmenopausalosteoporosiscorestabilitydynamic resistancebone mineral density

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    period of treatment was 4 successive months.

Study Arms (2)

placepo group

EXPERIMENTAL

Alendronate: the experimental and control group received (Alendronate) 70 mg 1 tab every week for 4 months.

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.

Other: AlendronateOther: treatment exercises

Interventions

control group received (Alendronate) 70 mg 1 tab every week.

exercises and alendronate groupplacepo group

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.

exercises and alendronate group

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy, Cairo university

Giza, 12662, Egypt

Location

MeSH Terms

Conditions

Osteoporosis, PostmenopausalOsteoporosis

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Hala Emara, phd

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investgator

Study Record Dates

First Submitted

February 9, 2024

First Posted

February 20, 2024

Study Start

February 1, 2024

Primary Completion

May 30, 2024

Study Completion

June 2, 2024

Last Updated

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations