Bone Mineral Density in Women With Uterine Fibroids or Endometriosis

Sponsor

Myovant Sciences GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT03744507

Collaborator

(none)

660

Enrollment

Locations

23.9

Actual Duration (Months)

10.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroid Endometriosis

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

660 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 3, 2018

Actual Primary Completion Date :

Jul 31, 2020

Actual Study Completion Date :

Jul 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Uterine Fibroids Premenopausal women with uterine fibroids confirmed by an ultrasound.
Endometriosis Premenopausal women with endometriosis diagnosed or confirmed by surgical or direct visualization, or histopathology within 10 years of the Screening visit.

Outcome Measures

Primary Outcome Measures

Percentage change in Bone Mineral Density (BMD) in lumbar spine (L1-L4). [from Baseline up to Week 52]
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Percentage change in BMD in the femoral neck and total hip. [from Baseline up to Week 52]
Assessed by DXA scan.
Absolute change in BMD in the lumbar spine (L1-L4), femoral neck and total hip. [from Baseline up to Week 52]
Assessed by dual-energy X-ray absorptiometry (DXA) scan.

Secondary Outcome Measures

Healthcare utilization for uterine fibroids or endometriosis [over 52 weeks]
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.
Frequency of concomitant medication use. [over 52 weeks]
Assessed through participants self-reporting.
Change from Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L). [from Baseline up to Week 52]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Inclusion Criteria:

Is a premenopausal female 18 to 50 years old
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.
Has one of the following conditions:
Diagnosis of uterine fibroids that is confirmed by an ultrasound within 5 years prior to screening.
Diagnosis of endometriosis confirmed by surgical or direct visualization and/or histopathologic confirmation.
Has not and is not expected to undergo a surgical procedure with bilateral oophorectomy within the 12 months following enrollment.

Exclusion Criteria:

Has a weight that exceeds the weight limit of the dual-energy X-ray absorptiometry scanner
Has a baseline BMD z-score < -2.0 at spine, total hip, or femoral neck
Has a history of or currently has osteoporosis, or other metabolic bone disease
Use within the past 3 months prior to Screening or anticipated use of systemic glucocorticoids
Is currently pregnant or lactating, or intends to become pregnant during the study period

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mobile	Mobile	Alabama	United States	36608
2	Mesa	Mesa	Arizona	United States	85215
3	Huntington Beach	Huntington Beach	California	United States	92647
4	Palos Verdes Estates	Palos Verdes Estates	California	United States	90274
5	Denver	Denver	Colorado	United States	80209
6	United States, Colorado	Denver	Colorado	United States	80211
7	Aventura	Aventura	Florida	United States	33180
8	Jupiter	Jupiter	Florida	United States	33458
9	Loxahatchee	Loxahatchee Groves	Florida	United States	33470
10	Margate	Margate	Florida	United States	33063
11	Miami	Miami	Florida	United States	33126
12	Orange City	Orange City	Florida	United States	32763
13	Orlando	Orlando	Florida	United States	32835
14	Port St. Lucie	Port Saint Lucie	Florida	United States	34952
15	Sarasota	Sarasota	Florida	United States	34239
16	West Palm Beach	West Palm Beach	Florida	United States	33409
17	Atlanta	Atlanta	Georgia	United States	30328
18	Decatur	Decatur	Georgia	United States	30034
19	Norcross	Norcross	Georgia	United States	30093
20	Oak Brook	Oak Brook	Illinois	United States	60523
21	Towson	Towson	Maryland	United States	21204
22	Canton	Canton	Michigan	United States	48187
23	Durham	Durham	North Carolina	United States	27713
24	Raleigh	Raleigh	North Carolina	United States	27607
25	Winston-Salem	Winston-Salem	North Carolina	United States	27103
26	Columbus	Columbus	Ohio	United States	43231
27	Chattanooga	Chattanooga	Tennessee	United States	37404
28	Memphis	Memphis	Tennessee	United States	38119
29	Memphis	Memphis	Tennessee	United States	38120
30	Beaumont	Beaumont	Texas	United States	77702
31	Fort Worth	Fort Worth	Texas	United States	76104
32	Houston	Houston	Texas	United States	77030
33	Houston	Houston	Texas	United States	77054
34	San Antonio	San Antonio	Texas	United States	78258
35	Sugar Land	Sugar Land	Texas	United States	77479
36	Webster	Webster	Texas	United States	77598
37	Virginia Beach	Virginia Beach	Virginia	United States	23456
38	Blacktown	Blacktown	New South Wales	Australia	2148
39	Kanwal	Kanwal	New South Wales	Australia	2259
40	Sherwood	Sherwood	Queensland	Australia	4075
41	Nedlands	Nedlands	Western Australia	Australia	6009
42	Santiago	Santiago		Chile	7510186
43	Santiago	Santiago		Chile	8320165
44	Santiago	Santiago		Chile	8360160
45	Pisek	Pisek	Jihocesky KRAJ	Czechia	39701
46	Praha 10	Praha 10	Praha	Czechia	10034
47	Olomouc	Olomouc	Severomoravsky KRAJ	Czechia	772 00
48	Tbilisi	Tbilisi	Borjomi	Georgia	159
49	Tbilisi	Tbilisi		Georgia	159
50	Kecskemet	Kecskemet	Bacs-kiskun	Hungary	6000
51	Gyula	Gyula	Bekes	Hungary	5700
52	Szeged	Szeged	Csongrad	Hungary	6725
53	Debrecen	Debrecen	Hajdu-bihar	Hungary	4024
54	Lublin	Lublin	Lubelskie	Poland	20064
55	Lublin	Lublin	Lubelskie	Poland	20093
56	Warszawa	Warszawa	Mazowieckie	Poland	2066
57	Warszawa	Warszawa	Mazowieckie	Poland	2929
58	Biaystok	Białystok	Podlaskie	Poland	15224
59	Biaystok	Białystok	Podlaskie	Poland	15464
60	Katowice	Katowice	Slaskie	Poland	40081
61	Katowice	Katowice	Slaskie	Poland	40301
62	Skorzewo	Skorzewo	Wielkopolskie	Poland	60185
63	Szczecin	Szczecin	Zachodniopomorskie	Poland	71434