Clinical trial NCT03744507: Bone Mineral Density in Women With Uterine Fibroids or Endometriosis
Official title: A Prospective Observational Study of Bone Mineral Density in Women With Uterine Fibroids or Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Fibroid
Endometriosis
Keywords: Uterine leiomyoma
Uterine fibroids
Heavy menstrual bleeding
Menorrhagia
Endometriosis
Lead sponsor: Myovant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2018-11-16
Enrollment: 660
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with endometriosis or with uterine fibroids

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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage change in Bone Mineral Density (BMD) in lumbar spine (L1-L4).
timeFrame: from Baseline up to Week 52
measure: Percentage change in BMD in the femoral neck and total hip.
timeFrame: from Baseline up to Week 52
measure: Absolute change in BMD in the lumbar spine (L1-L4), femoral neck and total hip.
timeFrame: from Baseline up to Week 52
Secondary outcomes:
measure: Healthcare utilization for uterine fibroids or endometriosis
timeFrame: over 52 weeks
measure: Frequency of concomitant medication use.
timeFrame: over 52 weeks
measure: Change from Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L).
timeFrame: from Baseline up to Week 52
Other outcomes:
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facility: Jupiter
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facility: Norcross
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facility: Oak Brook
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facility: Durham
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facility: Raleigh
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facility: Winston-Salem
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city: Columbus
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facility: Columbus
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facility: Chattanooga
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city: Memphis
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state: Tennessee
city: Memphis
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facility: Memphis
state: Tennessee
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facility: Beaumont
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city: Houston
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facility: Houston
state: Texas
city: Houston
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facility: Houston
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facility: San Antonio
state: Texas
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facility: Sugar Land
state: Texas
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facility: Webster
state: Texas
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facility: Virginia Beach
state: Virginia
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country: Australia
facility: Blacktown
state: New South Wales
city: Kanwal
country: Australia
facility: Kanwal
state: New South Wales
city: Sherwood
country: Australia
facility: Sherwood
state: Queensland
city: Nedlands
country: Australia
facility: Nedlands
state: Western Australia
city: Santiago
country: Chile
facility: Santiago
city: Santiago
country: Chile
facility: Santiago
city: Santiago
country: Chile
facility: Santiago
city: Pisek
country: Czechia
facility: Pisek
state: Jihocesky KRAJ
city: Praha 10
country: Czechia
facility: Praha 10
state: Praha
city: Olomouc
country: Czechia
facility: Olomouc
state: Severomoravsky KRAJ
city: Tbilisi
country: Georgia
facility: Tbilisi
state: Borjomi
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country: Georgia
facility: Tbilisi
city: Kecskemet
country: Hungary
facility: Kecskemet
state: Bacs-kiskun
city: Gyula
country: Hungary
facility: Gyula
state: Bekes
city: Szeged
country: Hungary
facility: Szeged
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city: Debrecen
country: Hungary
facility: Debrecen
state: Hajdu-bihar
city: Lublin
country: Poland
facility: Lublin
state: Lubelskie
city: Lublin
country: Poland
facility: Lublin
state: Lubelskie
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country: Poland
facility: Warszawa
state: Mazowieckie
city: Warszawa
country: Poland
facility: Warszawa
state: Mazowieckie
city: Białystok
country: Poland
facility: Biaystok
state: Podlaskie
city: Białystok
country: Poland
facility: Biaystok
state: Podlaskie
city: Katowice
country: Poland
facility: Katowice
state: Slaskie
city: Katowice
country: Poland
facility: Katowice
state: Slaskie
city: Skorzewo
country: Poland
facility: Skorzewo
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Szczecin
state: Zachodniopomorskie
Study officials:
References: