Bone Mineral Density in Women With Uterine Fibroids or Endometriosis

Endometriosis Clinical Trial

Official title:

A Prospective Observational Study of Bone Mineral Density in Women With Uterine Fibroids or Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744507
• Other study ID #: MVT-601-034
• Secondary ID: 2018-001367-22
• Status: Completed
• Start date: August 3, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: November 2020
• Source: Myovant Sciences GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to characterize the longitudinal bone mineral density (BMD) in premenopausal women with uterine fibroids or endometriosis.

Description:

This is a prospective observational study to characterize longitudinal BMD of premenopausal women with uterine fibroids or endometriosis over the 52-week observational period. Approximately 660 participants will be recruited into two cohorts: (1) premenopausal women with uterine fibroids confirmed by an ultrasound (approximately 260 participants), and (2) premenopausal women with endometriosis diagnosed or confirmed by surgical or direct visualization, or histopathology within 10 years of the Screening visit (approximately 400 participants). Since age is a strong risk factor for BMD change over time, participants in this observational study will be matched by age category (18 to 24, 25 to 34, 35 to 44, and ≥45 years old), with participants enrolled in the interventional studies of relugolix. During the Screening/Baseline period, the participant should be assessed for eligibility, and baseline dual-energy X-ray absorptiometry (DXA) scan will be obtained. Bone densitometry (lumbar spine [L1-L4], total hip, and femoral neck) will be obtained and submitted for central reading at Baseline, Week 24, and Week 52. Information related to health care utilization for uterine fibroids or endometriosis and concomitant medications will be collected at every visit and during the phone calls at Week 12 and Week 36. Collection of adverse events in this study will be limited to protocol-specified procedure-related adverse events. Reports of pregnancy will also be collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Leiomyoma
• Uterine Fibroid

Locations

Country	Name	City	State
Australia	Blacktown	Blacktown	New South Wales
Australia	Kanwal	Kanwal	New South Wales
Australia	Nedlands	Nedlands	Western Australia
Australia	Sherwood	Sherwood	Queensland
Chile	Santiago	Santiago
Chile	Santiago	Santiago
Chile	Santiago	Santiago
Czechia	Olomouc	Olomouc	Severomoravsky KRAJ
Czechia	Pisek	Pisek	Jihocesky KRAJ
Czechia	Praha 10	Praha 10	Praha
Georgia	Tbilisi	Tbilisi	Borjomi
Georgia	Tbilisi	Tbilisi
Hungary	Debrecen	Debrecen	Hajdu-bihar
Hungary	Gyula	Gyula	Bekes
Hungary	Kecskemet	Kecskemet	Bacs-kiskun
Hungary	Szeged	Szeged	Csongrad
Poland	Biaystok	Bialystok	Podlaskie
Poland	Biaystok	Bialystok	Podlaskie
Poland	Katowice	Katowice	Slaskie
Poland	Katowice	Katowice	Slaskie
Poland	Lublin	Lublin	Lubelskie
Poland	Lublin	Lublin	Lubelskie
Poland	Skorzewo	Skorzewo	Wielkopolskie
Poland	Szczecin	Szczecin	Zachodniopomorskie
Poland	Warszawa	Warszawa	Mazowieckie
Poland	Warszawa	Warszawa	Mazowieckie
United States	Atlanta	Atlanta	Georgia
United States	Aventura	Aventura	Florida
United States	Beaumont	Beaumont	Texas
United States	Canton	Canton	Michigan
United States	Chattanooga	Chattanooga	Tennessee
United States	Columbus	Columbus	Ohio
United States	Decatur	Decatur	Georgia
United States	Denver	Denver	Colorado
United States	United States, Colorado	Denver	Colorado
United States	Durham	Durham	North Carolina
United States	Fort Worth	Fort Worth	Texas
United States	Houston	Houston	Texas
United States	Houston	Houston	Texas
United States	Huntington Beach	Huntington Beach	California
United States	Jupiter	Jupiter	Florida
United States	Loxahatchee	Loxahatchee Groves	Florida
United States	Margate	Margate	Florida
United States	Memphis	Memphis	Tennessee
United States	Memphis	Memphis	Tennessee
United States	Mesa	Mesa	Arizona
United States	Miami	Miami	Florida
United States	Mobile	Mobile	Alabama
United States	Norcross	Norcross	Georgia
United States	Oak Brook	Oak Brook	Illinois
United States	Orange City	Orange City	Florida
United States	Orlando	Orlando	Florida
United States	Palos Verdes Estates	Palos Verdes Estates	California
United States	Port St. Lucie	Port Saint Lucie	Florida
United States	Raleigh	Raleigh	North Carolina
United States	San Antonio	San Antonio	Texas
United States	Sarasota	Sarasota	Florida
United States	Sugar Land	Sugar Land	Texas
United States	Towson	Towson	Maryland
United States	Virginia Beach	Virginia Beach	Virginia
United States	Webster	Webster	Texas
United States	West Palm Beach	West Palm Beach	Florida
United States	Winston-Salem	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Myovant Sciences GmbH

Countries where clinical trial is conducted

United States,  Australia,  Chile,  Czechia,  Georgia,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in Bone Mineral Density (BMD) in lumbar spine (L1-L4).	Assessed by dual-energy X-ray absorptiometry (DXA) scan.	from Baseline up to Week 52
Primary	Percentage change in BMD in the femoral neck and total hip.	Assessed by DXA scan.	from Baseline up to Week 52
Primary	Absolute change in BMD in the lumbar spine (L1-L4), femoral neck and total hip.	Assessed by dual-energy X-ray absorptiometry (DXA) scan.	from Baseline up to Week 52
Secondary	Healthcare utilization for uterine fibroids or endometriosis	Assessed through participants self-reporting (may be aided by review of participant medical records). Healthcare utilization includes visits to gynecologists or other primary care providers, visits to urgent care, visits to emergency department, hospitalizations, procedures (diagnostic or surgical) or changes to medication concomitant related to uterine fibroids or endometriosis.	over 52 weeks
Secondary	Frequency of concomitant medication use.	Assessed through participants self-reporting.	over 52 weeks
Secondary	Change from Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L).	Assessed using participants responses on the EQ-5D-5L questionnaire. The EQ-5D-5L is a standardized measure of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses (from 1= no problem to 5= extreme problems).	from Baseline up to Week 52