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Pregnancy-associated Reduction in Bone Mineral Density: a Comparative Study Using REMS Technology Between Singleton and Twin Pregnancies in the Third Trimester

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This clinical study aims to monitor and evaluate bone mineral density and fracture risk in women with singleton and twin pregnancies through the combined use of: * two specific questionnaires developed by the Fragility Fracture Observatory (OFF), and * a bone densitometric examination using REMS technology, performed between the 35th and 41st week of gestation. Primary objective: • To identify, in the third trimester of pregnancy (between the 35th and 41st gestational week), any differences in bone mineral density (BMD) between women with singleton pregnancies and women with dichorionic and monochorionic twin pregnancies. Secondary objectives: * Evaluate the relationship between bone mineral density (BMD) values and maternal clinical and historical parameters, such as age, body mass index (BMI), and obstetric and medical history. * Evaluate the association between BMD values and scores obtained from validated questionnaires administered to investigate fracture risk and bone health-related quality of life in women with singleton and twin pregnancies.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 45
Healthy Volunteers: t
View:

• Signed informed consent

• Willingness to participate in the study and ability to complete the study questionnaires

• Women between 35 and 41 weeks of gestational age at the time of study inclusion

• Singleton or twin pregnancy (dichorionic or monochorionic)

• Age between 30 and 45 years at the time of study recruitment

• No history of recent or previous bone fractures or traumatic fractures, and no motor disabilities (in the mother).

• Absence of a diagnosis of osteopenia or osteoporosis according to the criteria of the Italian Society for Osteoporosis, Mineral Metabolism and Bone Diseases (SIOMMMS).

• No intake of vitamin D or other medications during pregnancy.

• Absence of current or previous conditions that could potentially interfere with bone metabolism (e.g., thyroid, kidney, or liver disease).

⁃ Women of normal weight or with class I obesity (BMI between 18.5 and 34).

Locations
Other Locations
Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
RECRUITING
Roma
Contact Information
Primary
Tullio Ghi
tullio.ghi@policlinicogemelli.it
0630155989
Time Frame
Start Date: 2025-12-23
Estimated Completion Date: 2027-12-23
Participants
Target number of participants: 100
Treatments
Experimental: singleton pregnancy
Women in physiological pregnancy between the 35th and 41st week, with a single pregnancy
Experimental: Twin pregnancy
Women in physiological pregnancy between the 35th and 41st week, with a single pregnancy
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov