Osteoporosis and Fracture Risk in Pregnant WomenPOINCT07031557
Pregnancy and Lactation- Associated Osteoporosis
An observational study of Osteoporosis and Fracture Risk in Pregnant Women, run by Parma University Hospital at 1 site in Italy.
Trial summary
Pregnancy-Associated Osteoporosis is a condition characterized by loss of bone mass and fragility fractures during pregnancy or breastfeeding, often due to the increased calcium request from fetus. It typically manifests from the third trimester of pregnancy or in the early months of breastfeeding. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis and Fracture Risk in Pregnant Women
- What is being tested?
- EchoStation Implementing REMS Technology and Nutritional and Fracture Risk Assessment Questionnaires
- Type of treatment
- Medical device
- How many people
- 1,230 participants
- Where
- 1 siteItaly
- Study dates
- 9 Sep 2024to 8 Sep 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: A cohort of 1230 pregnant women aged 18-45 years and BMI between 18.5 and 34 without secondary osteoporosis and potential pathological conditions that may affect bone health.
Who may be able to join
- Signature informed consent
- Willingness to participate in the study and ability to complete the study-related questionnaires
- Women in the first trimester of pregnancy at the time of inclusion in the study
- Age between 18 and 45 years at the time of recruitment in the study
- Absence of secondary osteoporosis (induced by diseases or medication use)
- Absence of current or past conditions that could potentially interfere with bone metabolism (e.g., thyroid, kidney, or liver diseases)
- Women of normal weight or with class I obesity (BMI between 18,5 and 34)
Who cannot join
- Absence of informed consent
- Low compliance and/or inability to complete the study-related questionnaires
- Women not beyond the first trimester of pregnancy and pregnancy-related or pre-existing comorbidities
- Age under 18 or over 45 years
- BMI less than 18.5 or greater than 34
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteoporosis Project in Pregnancy and Lactation (POI)
Pregnancy-Associated Osteoporosis is a condition characterized by loss of bone mass and fragility fractures during pregnancy or breastfeeding, often due to the increased calcium request from fetus. It typically manifests from the third trimester of pregnancy or in the early months of breastfeeding. Therefore, early diagnosis is crucial to prevent fractures and vertebral collapses.
The study aims to monitor bone mineral density (BMD) and fracture risk in pregnant and breastfeeding women using:
- Questionnaires on calcium intake, dietary habits (Predimed), and fracture risk (AFEF);
- Ultrasound densitometry (REMS) in the first and third trimester of pregnancy and during breastfeeding.
- Being tested
- EchoStation Implementing REMS Technology, Nutritional and Fracture Risk Assessment Questionnaires
- Keywords
- Pregnancy-Associated Osteoporosis, REMS
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchoStation Implementing REMS TechnologyDevice
Also called EchoStation (Echolight S.p.A.)
Ultrasound-based densitometry used for the prevention, diagnosis, and monitoring of bone health status and fracture risk at reference anatomical sites (femur and spine), including all patient categories.
Nutritional and Fracture Risk Assessment QuestionnairesOther
Questionnaires regarding Calcium Intake, dietary habits assessment (Predimed), and Algorithm for Fracture Risk in Women of Childbearing Age (AFEF) developed by the Fragility Fracture Observatory (OFF)
| Study group | Role | What they receive |
|---|---|---|
| Pregnant and Breastfeeding Women | Participants in this cohort are pregnant women enrolled during their first trimester and followed up through the third trimester and the breastfeeding period. They will undergo a structured assessment of bone health, including completion of
* two standardized questionnaires, Calcium Intake and Dietary Habits Questionnaire, based on the PREDIMED score to assess adherence to the Mediterranean diet;
* AFEF Questionnaire (Algorithm for Fracture Risk in Women of Fertile Age), to evaluate clinical, anthropometric, pharmacological and lifestyle risk factors for fragility fractures.
Additionally, they will use REMS technology to monitor bone health, with periodic evaluations (first trimester, third trimester, and six months postpartum) for bone mineral density (BMD, g/cm²) and Fragility Score (0-100 scale) measurements. Receives: Device: EchoStation Implementing REMS Technology; Other: Nutritional and Fracture Risk Assessment Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium- intake Questionnaire
Daily calcium intake will be estimated using a semi-quantitative dietary questionnaire developed by the Fragility Fracture Observatory (OFF). The questionnaire collects data on the consumption frequency and portion size of calcium-rich foods. Results will be analyzed to determine whether calcium intake meets the physiological needs during pregnancy and breastfeeding.
There is no predefined score; intake will be expressed in estimated milligrams (mg) of calcium per day based on food composition and reported consumption patterns.
Measured: Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum
AFEF Questionnaire
Fracture risk will be assessed through the AFEF (Algorithm for Fracture Risk in Women of Fertile Age) questionnaire developed by the Fragility Fracture Observatory (OFF). The questionnaire is a non-scoring, structured tool collecting detailed information on anthropometrics (e.g., weight and height), personal and family medical history, lifestyle factors (e.g., smoking), and pharmacological treatments before and during pregnancy.
No numerical score is generated. Risk profiles will be evaluated qualitatively based on the presence or absence of recognized clinical risk factors for fragility fractures.
Measured: Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum
PREDIMED Score for Mediterranean Diet Adherence
Adherence to the Mediterranean diet will be assessed using the validated PREDIMED questionnaire, which includes 14 items evaluating dietary habits. Each item is scored as 1 (adherent) or 0 (non-adherent), for a total score ranging from 0 to 14.
Scores are interpreted as follows: ≤5 = Low adherence, 6-9 = Moderate adherence, ≥10 = High adherence.
Higher scores indicate better adherence to the Mediterranean diet.
Measured: Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum
Secondary outcomes (2)
Change in Bone Mineral Density (BMD) at the Proximal Femur Assessed by REMS During Pregnancy and Breastfeeding
To monitor longitudinal changes in bone structure by measuring Bone Mineral Density (BMD unit g/cm²) using Radiofrequency Echographic Multi Spectrometry (REMS) at the proximal femur. Assessments will occur during the first trimester, third trimester of pregnancy and during breastfeeding. Results will be reported separately for participants stratified into two baseline BMD groups (normal vs. reduced).
Measured: Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum
Fragility Score (FS) Measured by REMS at the Proximal Femur During Pregnancy and Breastfeeding
To evaluate the risk factors that lead to variations in bone fragility, through the use of the REMS-based Fragility Score (FS) parameter, identifying the cut-off value for femoral FS specific to pregnant women.
Unit of Measure of Fragility Score (FS), scale 0-100, where higher FS values represent increased fragility.
Measured: Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start9 Sep 2024
- Primary completion8 Sep 2025 (estimated)
- Study completion8 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis and Fracture Risk in Pregnant WomenStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,230 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Parma University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tullio Ghi, Parma University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031557
- Sponsor's protocol ID
- POI
- Acronym
- POI
- Status last verified
- Jun 2025
- First submitted
- 3 Mar 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis Project in Pregnancy and Lactation (POI)
- ClinicalTrials.gov ID
- NCT07031557
- Acronym / sponsor ID
- POI / POI
- Keywords
- Pregnancy-Associated Osteoporosis, REMS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,230 participants (actual)
- Lead sponsor
- Parma University HospitalUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 8 Sep 2025 (estimated)
- Study completion
- 8 Sep 2026 (estimated)
- First posted
- 22 Jun 2025 (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.
Pregnancy-Associated Osteoporosis is a condition characterized by loss of bone mass and fragility fractures during pregnancy or breastfeeding, often due to the increased calcium request from fetus. It typically manifests from the third trimester of pregnancy or in the early months of breastfeeding. Therefore, early diagnosis is crucial to prevent fractures and vertebral collapses.
The study aims to monitor bone mineral density (BMD) and fracture risk in pregnant and breastfeeding women using:
- Questionnaires on calcium intake, dietary habits (Predimed), and fracture risk (AFEF);
- Ultrasound densitometry (REMS) in the first and third trimester of pregnancy and during breastfeeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant and Breastfeeding Women | – | Device: EchoStation Implementing REMS Technology, Other: Nutritional and Fracture Risk Assessment QuestionnairesParticipants in this cohort are pregnant women enrolled during their first trimester and followed up through the third trimester and the breastfeeding period. They will undergo a structured assessment of bone health, including completion of * two standardized questionnaires, Calcium Intake and Dietary Habits Questionnaire, based on the PREDIMED score to assess adherence to the Mediterranean diet; * AFEF Questionnaire (Algorithm for Fracture Risk in Women of Fertile Age), to evaluate clinical, anthropometric, pharmacological and lifestyle risk factors for fragility fractures. Additionally, they will use REMS technology to monitor bone health, with periodic evaluations (first trimester, third trimester, and six months postpartum) for bone mineral density (BMD, g/cm²) and Fragility Score (0-100 scale) measurements. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A cohort of 1230 pregnant women aged 18-45 years and BMI between 18.5 and 34 without secondary osteoporosis and potential pathological conditions that may affect bone health.
Key inclusion criteria (7 listed)
- Signature informed consent
- Willingness to participate in the study and ability to complete the study-related questionnaires
- Women in the first trimester of pregnancy at the time of inclusion in the study
- Age between 18 and 45 years at the time of recruitment in the study
- Absence of secondary osteoporosis (induced by diseases or medication use)
Key exclusion criteria (5 listed)
- Absence of informed consent
- Low compliance and/or inability to complete the study-related questionnaires
- Women not beyond the first trimester of pregnancy and pregnancy-related or pre-existing comorbidities
- Age under 18 or over 45 years
- BMI less than 18.5 or greater than 34
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 |
|---|---|---|
| EchoStation Implementing REMS TechnologyAlso: EchoStation (Echolight S.p.A.)Ultrasound-based densitometry used for the prevention, diagnosis, and monitoring of bone health status and fracture risk at reference anatomical sites (femur and spine), including all patient categories. | Device | Pregnant and Breastfeeding Women |
| Nutritional and Fracture Risk Assessment QuestionnairesQuestionnaires regarding Calcium Intake, dietary habits assessment (Predimed), and Algorithm for Fracture Risk in Women of Childbearing Age (AFEF) developed by the Fragility Fracture Observatory (OFF) | Other | Pregnant and Breastfeeding Women |
Primary outcome
Calcium- intake Questionnaire
Time frame: Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum
Daily calcium intake will be estimated using a semi-quantitative dietary questionnaire developed by the Fragility Fracture Observatory (OFF). The questionnaire collects data on the consumption frequency and portion size of calcium-rich foods. Results will be analyzed to determine whether calcium intake meets the physiological needs during pregnancy and breastfeeding. There is no predefined score; intake will be expressed in estimated milligrams (mg) of calcium per day based on food composition and reported consumption patterns.
AFEF Questionnaire
Time frame: Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum
Fracture risk will be assessed through the AFEF (Algorithm for Fracture Risk in Women of Fertile Age) questionnaire developed by the Fragility Fracture Observatory (OFF). The questionnaire is a non-scoring, structured tool collecting detailed information on anthropometrics (e.g., weight and height), personal and family medical history, lifestyle factors (e.g., smoking), and pharmacological treatments before and during pregnancy. No numerical score is generated. Risk profiles will be evaluated qualitatively based on the presence or absence of recognized clinical risk factors for fragility fractures.
PREDIMED Score for Mediterranean Diet Adherence
Time frame: Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum
Adherence to the Mediterranean diet will be assessed using the validated PREDIMED questionnaire, which includes 14 items evaluating dietary habits. Each item is scored as 1 (adherent) or 0 (non-adherent), for a total score ranging from 0 to 14. Scores are interpreted as follows: ≤5 = Low adherence, 6-9 = Moderate adherence, ≥10 = High adherence. Higher scores indicate better adherence to the Mediterranean diet.
2 secondary outcomes
Change in Bone Mineral Density (BMD) at the Proximal Femur Assessed by REMS During Pregnancy and Breastfeeding
Time frame: Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum
Fragility Score (FS) Measured by REMS at the Proximal Femur During Pregnancy and Breastfeeding
Time frame: Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Fracture Risk in Pregnant Women, run by Parma University Hospital at 1 site in Italy.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 5 Sep 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Calcium- intake Questionnaire (time frame: Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum). The study lists 3 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 5 Sep 2025.