Bone Mineral Density Quantitative Trait Locus 3Phase 1NCT02480023
Assessment of Bone Mineral Density During Pregnancy
A Phase 1 study testing calcaneal quantitative ultrasound assessment in people with Bone Mineral Density Quantitative Trait Locus 3, run by Ain Shams University at 1 site in Egypt.
Trial summary
BMD at peripheral sites typically heel is measured by Ultrasound densitometry at Ain Shams Maternity hospital. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Bone Mineral Density Quantitative Trait Locus 3
- What is being tested?
- calcaneal quantitative ultrasound assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2015to Jan 2016
- Phase
- Phase 1
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. females during 3rd trimister
Who cannot join
- 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.
- Histories of smoking and use of oral contraceptives (OCs) are not exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Bone Mineral Density as Measured by Calcaneal Quantitative Ultrasound in Third Trimester of Pregnancy
BMD at peripheral sites typically heel is measured by Ultrasound densitometry at Ain Shams Maternity hospital.
Read the detailed 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.
- Being tested
- calcaneal quantitative ultrasound assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcaneal quantitative ultrasound assessmentRadiation
QUS for calcaneus bone of right foot will be done for this group of Pregnant women at the third trimester
| Study group | Role | What they receive |
|---|---|---|
| healthcare | Experimental | QUS for calcaneus bone of right foot will be done for this group of Pregnant women at the third trimester Receives: Radiation: calcaneal quantitative ultrasound assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density loss during pregnancy that is detectable by quantitative ultrasound at the os calcis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Mineral Density Quantitative Trait Locus 3Studies of the same condition, open and under way.
- More trials run by Ain Shams 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 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr mohamed laban, Ain Shams University
- Investigators
- mohamed laban, MD, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480023
- Sponsor's protocol ID
- osteopenia during pregnancy
- Status last verified
- Jan 2016
- First submitted
- 19 Jun 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Bone Mineral Density as Measured by Calcaneal Quantitative Ultrasound in Third Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT02480023
- Acronym / sponsor ID
- osteopenia during pregnancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Jun 2015 (estimated)
- 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.
BMD at peripheral sites typically heel is measured by Ultrasound densitometry at Ain Shams Maternity hospital.
Detailed 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthcare | Experimental | Radiation: calcaneal quantitative ultrasound assessmentQUS for calcaneus bone of right foot will be done for this group of Pregnant women at the third trimester |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. females during 3rd trimister
Key exclusion criteria (5 listed)
- 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.
- Histories of smoking and use of oral contraceptives (OCs) are not exclusion criteria.
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 |
|---|---|---|
| calcaneal quantitative ultrasound assessmentQUS for calcaneus bone of right foot will be done for this group of Pregnant women at the third trimester | Radiation | healthcare |
Primary outcome
Bone mineral density loss during pregnancy that is detectable by quantitative ultrasound at the os calcis.
Time frame: 6 months
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 12 Jan 2016.
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.
mohamed laban, MD study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing calcaneal quantitative ultrasound assessment in people with Bone Mineral Density Quantitative Trait Locus 3, run by Ain Shams 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 1 inclusion and 5 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 12 Jan 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bone mineral density loss during pregnancy that is detectable by quantitative ultrasound at the os calcis. (time frame: 6 months). 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 12 Jan 2016.