Presentation and clinical outcome of pregnancy-associated osteoporosis

Not Applicable

• Conditions: Pregnancy-associated osteoporosis; Pregnancy and Childbirth

• Registration Number: ISRCTN27082949
• Lead Sponsor: Accord (United Kingdom)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-17
• Last Update Posted: 19 December 2023
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

PAO cases:
1. Previously diagnosed with PAO
2. Willing and able to give informed consent

Controls:
1. Women known to a PAO participant who had a baby around the same time as a participant who was not diagnosed with PAO
2. Willing and able to give informed consent

Exclusion Criteria

Does not meet the inclusion criteria

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone mineral density change in relation to treatment received (if any), measured using dual-energy x-ray absorptiometry (DEXA) at all timepoints available after the initial diagnosis for up to 5 years

Secondary Outcome Measures

Name	Time	Method
1. Quality of life measured using SF36 at diagnosis recorded retrospectively at the time of answering the survey<br>2. Participant reported fracture number and type at diagnosis recorded retrospectively at the time of answering the survey<br>3. Validated fractures recorded on the participant's medical record at the original diagnosis and following the original diagnosis for up to 5 years <br>4. Recurrence of fractures during subsequent pregnancies as recorded on the participant’s medical record at any timepoint