Assessment of Bone Mineral Density During Pregnancy

Bone Mineral Density Quantitative Trait Locus 3 Clinical Trial

Official title:

Changes in Bone Mineral Density as Measured by Calcaneal Quantitative Ultrasound in Third Trimester of Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480023
• Other study ID #: osteopenia during pregnancy
• Status: Completed
• Phase: Phase 1
• First received: June 19, 2015
• Last updated: January 9, 2016
• Start date: June 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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

Description:

Consecutive patients with singleton pregnancies between 36 and 39 weeks booked at a general obstetric clinic in a regional hospital will be recruited for the study. The obstetric department is a tertiary referral center in the region and part of a university teaching unit which catered to an annual delivery of around 10,000 women. A group of first trimester pregnant women with nearly the same age is recruited as controls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. females during 3rd trimister

Exclusion Criteria:

1. Secondary causes of bone loss such as hyperparathyroidism.

2. Co-morbidities that would interfere with bone metabolism as clinically significant liver or renal disease.

3. Physical or orthopedic disabilities that would place the subject at risk or limit their ability to perform US.

4. Taking medication known to affect bone including steroid hormones.

Histories of smoking and use of oral contraceptives (OCs) are not exclusion criteria.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Bone Mineral Density Quantitative Trait Locus 3

Intervention

Radiation:
• calcaneal quantitative ultrasound assessment
QUS for calcaneus bone of right foot will be done for this group of Pregnant women at the third trimester

Locations

Country	Name	City	State
Egypt	Faculty of medicine, ain shams university	Cairo	Al Qahirah

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density loss during pregnancy that is detectable by quantitative ultrasound at the os calcis.		6 months	Yes