Heavy Menstrual Bleeding, Uterine Fibroids
Conditions
Keywords
Elagolix Sodium, Heavy Menstrual Bleeding (HMB), Heavy Uterine Bleeding, Leiomyomata, Menorrhagia, Elagolix + Norethindrone Acetate, Elagolix + E2/NETA, Elagolix, Safety, Efficacy
Brief summary
This randomized multicenter phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study was double-blind (DB) during the first 12 months and open-label (OL) for the next 36 months.
Detailed description
478 participants were randomly assigned at a ratio of 2:1 to the following treatment groups: 1. Elagolix 300 mg twice daily (BID) plus estradiol 1.0 mg/norethindrone acetate 0.5 mg (E2/NETA) once daily (QD) for 48 months, followed by 12 months PTFU 2. Placebo for 12 months, followed by elagolix 300 mg BID plus E2/NETA QD for 36 months, followed by 12 months PTFU This study was double-blinded during the first 12 months and open-label for the next 36 months. Participants entered up to 12 months of PTFU after completing treatment Month 48 (or at any time a participant prematurely discontinued treatment).
Interventions
DRUGElagolix
Film-coated 300 mg tablets
DRUGEstradiol /norethindrone acetate (E2/NETA)
Estradiol 1 mg/norethindrone acetate 0.5 mg capsules
OTHERE2/NETA Placebo
Placebo capsules
OTHERElagolix Placebo
Film-coated placebo tablets
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Participant is a premenopausal female at the time of Screening. * Participant has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound \[Transabdominal ultrasound (TAU) or transvaginal ultrasound (TVU)\]. * Participant has Heavy Menstrual Bleeding (HMB) associated with uterine fibroids as evidenced by Menstrual Blood Loss (MBL) \> 80 mL during each of two screening menses as measured by the alkaline hematin method. * Participant has negative urine and/or serum pregnancy test during Washout (if applicable) and/or Screening and just prior to first dose. * Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology.
Exclusion criteria
* Participant has screening pelvic ultrasound or Saline Infusion Sonohysterography (SIS) results that show a clinically significant gynecological disorder. * Participant has history of osteoporosis or other metabolic bone disease. * Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis. * Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder). * Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or intra-articular injectable (for occasional use) corticosteroids are allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Baseline to 60 months | An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. AEs during the 12-month DB period were defined as any AEs with onset on/after first dose of study drug during the DB period and no more than 30 days after the last dose of study drug for participants who discontinued early during the DB period, or until the first dose of study drug in the OL period for participants who entered the OL Treatment Period. AEs during the OL period were defined as AEs with onset on/after first dose of study drug during the OL period and no more than 30 days after the last dose of study drug. During the post-treatment follow-up (PTFU) period, adverse events were collected from 30 days post-last dose until end of study. Safety reporting during the PTFU period included AESIs. Other AEs may have also been reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Baseline through Month 60 | Percent Recovery of BMD after 6 and 12 months of post-treatment follow-up (PTFU) for Spine, Total Hip, and Femoral Neck. BMD assessments were measured by dual X-ray absorptiometry (DXA). Analysis excludes participants who switched machine manufacturer type. Percent recovery is defined as 100\*(% change from Baseline to final on-treatment assessment - % change from Baseline to post-treatment visit) / (% change from Baseline to final on treatment assessment) and is defined only for subjects with BMD decrease at final on-treatment assessment. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
A total of 478 participants were enrolled across the United States and Puerto Rico.
Participants by arm
| Arm | Count |
|---|---|
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) Participants were randomized to receive elagolix 300 mg BID plus E2/NETA (estradiol 1 mg/norethindrone acetate 0.5 mg QD) for 48 months followed by 12 months post-treatment follow-up | 319 |
| Placebo Participants were randomized to receive placebo for 12 months, followed by elagolix 300 mg BID plus E2/NETA (estradiol 1 mg/norethindrone acetate 0.5 mg QD) for 36 months followed by 12 months post-treatment follow-up | 159 |
| Total | 478 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-Blind (DB) Period | Adverse Event | 4 | 1 |
| Double-Blind (DB) Period | Lost to Follow-up | 9 | 9 |
| Double-Blind (DB) Period | Missing | 1 | 0 |
| Double-Blind (DB) Period | Non-compliance with study procedures | 0 | 1 |
| Double-Blind (DB) Period | Other | 6 | 1 |
| Double-Blind (DB) Period | Requires surgery or invasive intervention for treatment of uterine fibroids | 3 | 2 |
| Double-Blind (DB) Period | Withdrawal by Subject | 13 | 10 |
| Open-Label (OL) Period | Adverse Event | 2 | 0 |
| Open-Label (OL) Period | Lost to Follow-up | 10 | 5 |
| Open-Label (OL) Period | Missing | 2 | 0 |
| Open-Label (OL) Period | Non-compliance with study procedures | 4 | 1 |
| Open-Label (OL) Period | No Specified | 2 | 2 |
| Open-Label (OL) Period | Withdrawal by Subject | 14 | 8 |
| Post-Treatment Follow-Up (PTFU) Period | Adverse Event | 16 | 6 |
| Post-Treatment Follow-Up (PTFU) Period | COVID-19 logistical restrictions | 1 | 0 |
| Post-Treatment Follow-Up (PTFU) Period | Lost to Follow-up | 35 | 24 |
| Post-Treatment Follow-Up (PTFU) Period | Missing | 3 | 2 |
| Post-Treatment Follow-Up (PTFU) Period | Non-compliance with study procedures | 9 | 2 |
| Post-Treatment Follow-Up (PTFU) Period | Other | 21 | 10 |
| Post-Treatment Follow-Up (PTFU) Period | Requires surgery or invasive intervention for treatment of uterine fibroids | 5 | 3 |
| Post-Treatment Follow-Up (PTFU) Period | Withdrawal by Subject | 40 | 26 |
Baseline characteristics
| Characteristic | Placebo | Total | Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) |
|---|---|---|---|
| Age, Continuous | 41.7 Years STANDARD_DEVIATION 5.65 | 42.3 Years STANDARD_DEVIATION 5.28 | 42.6 Years STANDARD_DEVIATION 5.07 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 108 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 128 Participants | 370 Participants | 242 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 99 Participants | 270 Participants | 171 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 51 Participants | 179 Participants | 128 Participants |
| Sex: Female, Male Female | 159 Participants | 478 Participants | 319 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 159 | 0 / 319 | 0 / 159 | 1 / 319 | 0 / 84 | 0 / 193 | 0 / 159 | 1 / 319 |
| other Total, other adverse events | 1 / 159 | 0 / 319 | 28 / 159 | 88 / 319 | 41 / 84 | 65 / 193 | 3 / 159 | 5 / 319 |
| serious Total, serious adverse events | 1 / 159 | 3 / 319 | 2 / 159 | 10 / 319 | 7 / 84 | 9 / 193 | 1 / 159 | 3 / 319 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. AEs during the 12-month DB period were defined as any AEs with onset on/after first dose of study drug during the DB period and no more than 30 days after the last dose of study drug for participants who discontinued early during the DB period, or until the first dose of study drug in the OL period for participants who entered the OL Treatment Period. AEs during the OL period were defined as AEs with onset on/after first dose of study drug during the OL period and no more than 30 days after the last dose of study drug. During the post-treatment follow-up (PTFU) period, adverse events were collected from 30 days post-last dose until end of study. Safety reporting during the PTFU period included AESIs. Other AEs may have also been reported.
Time frame: Baseline to 60 months
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Number of Participants With Adverse Events (AEs) | Double-blind Period | 203 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Number of Participants With Adverse Events (AEs) | Open-label Period | 124 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Number of Participants With Adverse Events (AEs) | Post-treatment Follow-up Period | 22 Participants |
| Placebo | Number of Participants With Adverse Events (AEs) | Double-blind Period | 83 Participants |
| Placebo | Number of Participants With Adverse Events (AEs) | Open-label Period | 59 Participants |
| Placebo | Number of Participants With Adverse Events (AEs) | Post-treatment Follow-up Period | 6 Participants |
Secondary
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Percent Recovery of BMD after 6 and 12 months of post-treatment follow-up (PTFU) for Spine, Total Hip, and Femoral Neck. BMD assessments were measured by dual X-ray absorptiometry (DXA). Analysis excludes participants who switched machine manufacturer type. Percent recovery is defined as 100\*(% change from Baseline to final on-treatment assessment - % change from Baseline to post-treatment visit) / (% change from Baseline to final on treatment assessment) and is defined only for subjects with BMD decrease at final on-treatment assessment.
Time frame: Baseline through Month 60
Population: Of the total participants in the Safety Analysis Set, each row includes participants with a BMD decrease from baseline at their final on-treatment visit (up to Month 48), in any location (spine, total hip or femoral neck), and at least 1 DXA scan during the follow-up period.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (12 months PTFU) | < 0% Recovery | 22 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (6 months PTFU) | > 100% Recovery | 9 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (12 months PTFU) | 0% - 25% Recovery | 11 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (12 months PTFU) | > 75% - 100% Recovery | 5 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (12 months PTFU) | > 25% - 50% Recovery | 7 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (6 months PTFU) | > 50% - 75% Recovery | 5 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (12 months PTFU) | > 50% - 75% Recovery | 6 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (12 months PTFU) | > 100% Recovery | 20 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (12 months PTFU) | > 75% - 100% Recovery | 5 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (12 months PTFU) | < 0% Recovery | 23 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (12 months PTFU) | > 100% Recovery | 15 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (6 months PTFU) | < 0% Recovery | 20 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (6 months PTFU) | < 0% Recovery | 22 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (6 months PTFU) | > 25% - 50% Recovery | 3 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (6 months PTFU) | 0% - 25% Recovery | 5 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (6 months PTFU) | 0% - 25% Recovery | 5 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (6 months PTFU) | > 25% - 50% Recovery | 8 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (12 months PTFU) | 0% - 25% Recovery | 3 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (6 months PTFU) | > 50% - 75% Recovery | 5 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (6 months PTFU) | > 25% - 50% Recovery | 5 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (6 months PTFU) | > 75% - 100% Recovery | 4 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (6 months PTFU) | > 75% - 100% Recovery | 5 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (6 months PTFU) | > 100% Recovery | 7 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (6 months PTFU) | > 50% - 75% Recovery | 7 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (12 months PTFU) | < 0% Recovery | 18 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (12 months PTFU) | > 25% - 50% Recovery | 5 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (12 months PTFU) | 0% - 25% Recovery | 12 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (6 months PTFU) | > 75% - 100% Recovery | 1 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (12 months PTFU) | > 25% - 50% Recovery | 7 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (6 months PTFU) | 0% - 25% Recovery | 8 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (12 months PTFU) | > 50% - 75% Recovery | 6 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (6 months PTFU) | > 100% Recovery | 13 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (12 months PTFU) | > 75% - 100% Recovery | 3 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (12 months PTFU) | > 50% - 75% Recovery | 9 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (12 months PTFU) | > 100% Recovery | 14 Participants |
| Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (6 months PTFU) | < 0% Recovery | 24 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (12 months PTFU) | > 100% Recovery | 5 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (6 months PTFU) | < 0% Recovery | 10 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (6 months PTFU) | 0% - 25% Recovery | 2 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (6 months PTFU) | > 25% - 50% Recovery | 2 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (6 months PTFU) | > 50% - 75% Recovery | 2 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (6 months PTFU) | > 75% - 100% Recovery | 1 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (6 months PTFU) | > 100% Recovery | 2 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (12 months PTFU) | < 0% Recovery | 10 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (12 months PTFU) | 0% - 25% Recovery | 2 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (12 months PTFU) | > 25% - 50% Recovery | 1 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (12 months PTFU) | > 50% - 75% Recovery | 2 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (12 months PTFU) | > 75% - 100% Recovery | 0 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Spine (12 months PTFU) | > 100% Recovery | 7 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (6 months PTFU) | < 0% Recovery | 10 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (6 months PTFU) | 0% - 25% Recovery | 1 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (6 months PTFU) | > 25% - 50% Recovery | 4 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (6 months PTFU) | > 50% - 75% Recovery | 1 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (6 months PTFU) | > 75% - 100% Recovery | 0 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (6 months PTFU) | > 100% Recovery | 1 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (12 months PTFU) | < 0% Recovery | 12 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (12 months PTFU) | 0% - 25% Recovery | 1 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (12 months PTFU) | > 25% - 50% Recovery | 1 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (12 months PTFU) | > 50% - 75% Recovery | 2 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (12 months PTFU) | > 75% - 100% Recovery | 0 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Total Hip (12 months PTFU) | > 100% Recovery | 3 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (6 months PTFU) | < 0% Recovery | 10 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (6 months PTFU) | 0% - 25% Recovery | 2 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (6 months PTFU) | > 25% - 50% Recovery | 1 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (6 months PTFU) | > 50% - 75% Recovery | 4 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (6 months PTFU) | > 75% - 100% Recovery | 1 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (6 months PTFU) | > 100% Recovery | 2 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (12 months PTFU) | < 0% Recovery | 10 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (12 months PTFU) | 0% - 25% Recovery | 2 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (12 months PTFU) | > 25% - 50% Recovery | 1 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (12 months PTFU) | > 50% - 75% Recovery | 3 Participants |
| Placebo | Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment | Femoral Neck (12 months PTFU) | > 75% - 100% Recovery | 1 Participants |