Clinical trial · Observational
Bone Mineral Density in Women With Uterine Fibroids or Endometriosis
A Prospective Observational Study of Bone Mineral Density in Women With Uterine Fibroids or Endometriosis
NCT03744507CI-TRIAL-00048213completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to characterize the longitudinal bone mineral density (BMD) in premenopausal women with uterine fibroids or endometriosis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometriosis | — | UNRESOLVED | — |
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Uterine Fibroids
- description
- Premenopausal women with uterine fibroids confirmed by an ultrasound.
- label
- Endometriosis
- description
- Premenopausal women with endometriosis diagnosed or confirmed by surgical or direct visualization, or histopathology within 10 years of the Screening visit.
Primary outcomes (3)
- measure
- Percentage change in Bone Mineral Density (BMD) in lumbar spine (L1-L4).
- timeFrame
- from Baseline up to Week 52
- description
- Assessed by dual-energy X-ray absorptiometry (DXA) scan.
- measure
- Percentage change in BMD in the femoral neck and total hip.
- timeFrame
- from Baseline up to Week 52
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. Is a premenopausal female 18 to 50 years old 2. By the participant's report, had two consecutive regular menstrual cycles immediately prior to enrollment in the study. Participants with hormonal intrauterine devices or on other hormonal contraception methods that disrupt cyclic bleeding are not required to have two consecutive regular menstrual cycles. 3. Has one of the following conditions: 1. Diagnosis of uterine fibroids that is confirmed by an ultrasound within 5 years prior to screening. 2. Diagnosis of endometriosis confirmed by surgical or direct visualization and/or histopathologic confirmation. 4. Has not and is not expected to undergo a surgical procedure with bilateral oophorectomy within the 12 months following enrollment. Exclusion Criteria: 5. Has a weight that exceeds the weight limit of the dual-energy X-ray absorptiometry scanner 6. Has a baseline BMD z-score \< -2.0 at spine, total hip, or femoral neck 7. Has a history of or currently has osteoporosis, or other metabolic bone disease 8. Use within the past 3 months prior to Screening or anticipated use of systemic glucocorticoids 9. Is currently pregnant or lactating, or intends to become pregnant during the study period
References
Publications (0)
Data not yet available
No reference posted for this study.