NCT02480023

Brief Summary

BMD at peripheral sites typically heel is measured by Ultrasound densitometry at Ain Shams Maternity hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

June 19, 2015

Last Update Submit

January 9, 2016

Conditions

Bone Mineral Density Quantitative Trait Locus 3

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density loss during pregnancy that is detectable by quantitative ultrasound at the os calcis.

    6 months

Study Arms (1)

healthcare

EXPERIMENTAL

QUS for calcaneus bone of right foot will be done for this group of Pregnant women at the third trimester

Radiation: calcaneal quantitative ultrasound assessment

Interventions

calcaneal quantitative ultrasound assessmentRADIATION

QUS for calcaneus bone of right foot will be done for this group of Pregnant women at the third trimester

healthcare

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. females during 3rd trimister

You may not qualify if:

  • Secondary causes of bone loss such as hyperparathyroidism.
  • Co-morbidities that would interfere with bone metabolism as clinically significant liver or renal disease.
  • Physical or orthopedic disabilities that would place the subject at risk or limit their ability to perform US.
  • Taking medication known to affect bone including steroid hormones.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, ain shams university

Cairo, Cairo Governorate, Egypt

Location

Study Officials

  • mohamed laban, MD

    Ain Shams University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Mohamed Laban

Study Record Dates

First Submitted

June 19, 2015

First Posted

June 24, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

EG(1)