Phase 3 N=7,609 Randomized Double-blind Treatment

Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

Osteoporosis

Bottom Line

View on ClinicalTrials.gov: NCT00205777 ↗

Enrolled (actual)

7,609

Serious AEs

24.7%

Results posted

Apr 2013

Primary outcome: Primary: Percentage of Participants With New Vertebral Fractures Through Month 36 — 1.98; 2.14; 1.84; 3.13 Percentage of participants — p=0.22

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Bazedoxifene Acetate (Drug); Placebo (Other)
Age: Adult, Older Adult · 55+ yrs
Sex: Female
Sponsor: Pfizer
Primary completion: Sep 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With New Vertebral Fractures Through Month 36	1.98; 2.14; 1.84; 3.13; 2.63; 2.80	0.22
PRIMARY Percentage of Participants With New Vertebral Fractures Through Month 60	3.11; 5.40; 3.46; 5.67; 7.95; 4.28	0.097
PRIMARY Percentage of Participants With New Vertebral Fractures Through Month 84	8.18; 5.79; 11.35; 6.90	0.085
SECONDARY Incidence of Breast Cancer Through Month 36	1.09; 0.90; 1.55; 1.74	0.40
SECONDARY Incidence of Breast Cancer Through Month 60	1.40; 1.56; 1.43	—
SECONDARY Incidence of Breast Cancer Through Month 84	1.50; 1.52	—
SECONDARY Percentage of Participants With New Clinical Vertebral Fractures Through Month 36	0.72; 0.76; 0.87; 0.94	0.57
SECONDARY Percentage of Participants With New Clinical Vertebral Fractures Through Month 60	0.79; 1.37; 0.84	0.29
SECONDARY Percentage of Participants With New Clinical Vertebral Fractures Through Month 84	1.92; 1.28	0.18
SECONDARY Number of Participants With Worsening Vertebral Fractures Through Month 36	3; 2; 2; 1	—
SECONDARY Number of Participants With Worsening Vertebral Fractures Through Month 60	4; 1; 2	—
SECONDARY Number of Participants With Worsening Vertebral Fractures Through Month 84	1; 7	—
SECONDARY Percentage of Participants With Non-vertebral Fractures Through Month 36	5.68; 5.61; 5.87; 6.26; 0.55; 0.34	0.46
SECONDARY Percentage of Participants With Non-vertebral Fractures Through Month 60	9.47; 9.03; 7.59; 0.75; 0.65; 0.53	0.968
SECONDARY Percentage of Participants With Non-vertebral Fractures Through Month 84	10.77; 11.20; 1.34; 0.74; 3.62; 4.61	0.73
SECONDARY Change From Baseline in Height at Month 36	-3.7; -3.9; -4.5; -3.3	0.31
SECONDARY Change From Baseline in Height at Month 60	-0.50; -0.41; -0.41	0.12
SECONDARY Change From Baseline in Height at Month 84	-0.68; -0.73	0.26
SECONDARY Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36	1.53; 1.56; 1.79; 0.51; 0.75; 0.85	<0.001 sig
SECONDARY Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60	1.92; 0.84; 2.02; -0.17; -1.05; 0.11	<0.001 sig
SECONDARY Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84	1.80; 2.24; -1.96; -0.85; -2.12; -0.60	0.34
SECONDARY Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12	-23.48; -25.28; -26.18; -11.37; -32.75; -35.20	<0.001 sig
SECONDARY Percent Change From Baseline in Osteocalcin at Months 36 and 60	-23.91; -12.73; -26.99; -25.21; -17.21; -30.41	<0.001 sig
SECONDARY Percent Change From Baseline in Osteocalcin at Months 72 and 84	-26.72; -33.76; -29.50; -32.25	0.037 sig
SECONDARY Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12	-42.12; -45.11; -45.48; -26.17; -46.93; -50.00	<0.001 sig
SECONDARY Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60	-30.54; -21.85; -32.26; -26.80; -10.40; -27.87	<0.001 sig
SECONDARY Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84	-29.44; -37.41; -28.61; -28.17	0.034 sig
SECONDARY Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36	-3.89; -4.73; -5.50; 0.00; -8.55; -10.18	<0.001 sig
SECONDARY Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP	17.078; 19.155; 16.650; 17.144; 1.513; 1.644	0.97
SECONDARY Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP	20.315; 17.818; 21.590; 2.550; 0.893; 2.790	0.70
SECONDARY Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh	31.348; 31.689; 31.089; 30.447; 6.180; 6.085	0.22
SECONDARY Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh	34.250; 30.300; 28.700; 7.450; 5.500; 6.400	0.018 sig
SECONDARY Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG]	95.111; 110.897; 94.353; 105.912	0.35
SECONDARY Bone Histomorphometric Indices at Month 60: TSG	75.333; 75.560; 128.500	1.00
SECONDARY Bone Histomorphometric Indices at Month 36: TtAr	39.904; 42.334; 39.497; 41.459	0.71
SECONDARY Bone Histomorphometric Indices at Month 60: TtAr	28.767; 34.600; 41.200	0.73
SECONDARY Bone Histomorphometric Indices at Month 36: BFP, RP and RmP	0.463; 0.441; 0.751; 0.436; 0.080; 0.066	0.81
SECONDARY Bone Histomorphometric Indices at Month 60: BFP, RP and RmP	0.545; 0.820; 0.390; 0.035; 0.035; 0.020	0.60
SECONDARY Bone Histomorphometric Indices at Month 36: SuD	2.405; 2.632; 2.424; 2.587	0.22
SECONDARY Bone Histomorphometric Indices at Month 60: SuD	2.625; 2.248; 3.120	0.41
SECONDARY Bone Histomorphometric Indices at Month 36: BFRTS	0.013; 0.012; 0.009; 0.012	0.68
SECONDARY Bone Histomorphometric Indices at Month 60: BFRTS	0.013; 0.006; 0.018	0.25
SECONDARY Bone Histomorphometric Indices at Month 36: ACF	0.421; 0.385; 0.290; 0.410	0.90
SECONDARY Bone Histomorphometric Indices at Month 60: ACF	0.375; 0.198; 0.610	0.25
SECONDARY Bone Histomorphometric Indices at Month 36: Mlt	31.650; 30.337; 48.383; 29.533	0.77
SECONDARY Bone Histomorphometric Indices at Month 60: Mlt	43.450; 51.100; 31.900	0.79
SECONDARY Bone Histomorphometric Indices at Month 36: MAR	0.578; 0.563; 0.520; 0.550	0.30
SECONDARY Bone Histomorphometric Indices at Month 60: MAR	0.525; 0.573; 0.490	0.70
SECONDARY Bone Histomorphometric Indices at Month 36: TbN	1.202; 1.315; 1.212; 1.293	0.22
SECONDARY Bone Histomorphometric Indices at Month 60: TbN	1.315; 1.125; 1.560	0.41
SECONDARY Bone Histomorphometric Indices at Month 36: BFRBV	0.186; 0.171; 0.122; 0.187	0.97
SECONDARY Bone Histomorphometric Indices at Month 60: BFRBV	0.167; 0.075; 0.253	0.15
SECONDARY Women's Health Questionnaire (WHQ)	0.342; 0.348; 0.341; 0.343; 0.339; 0.343	—
SECONDARY Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36	0.000; 0.001; 0.001; -0.005; 0.005; 0.006	0.20
SECONDARY European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO)	24.57; 24.50; 23.98; 24.31; 24.33; 24.24	—
SECONDARY Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36	-0.24; -0.91; -0.49; -0.77; -0.00; 0.02	0.080
SECONDARY Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)	79.20; 80.89; 82.23; 80.95; 79.11; 80.73	—
SECONDARY Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36	1.59; 0.12; -1.39; -0.37; 0.45; -1.13	0.21
SECONDARY Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score	0.81; 0.82; 0.82; 0.81; 0.81; 0.82	—
SECONDARY Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36	0.01; 0.01; 0.01; 0.01; 0.00; -0.01	0.72

Summary

The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.

Eligibility Criteria

Inclusion Criteria

Must be at least 2 years postmenopausal
Osteoporotic subjects without vertebral fracture who meet BMD criteria, or Osteoporotic subjects with vertebral fracture

Exclusion Criteria

Diseases that may affect bone metabolism
Vasomotor symptoms requiring treatment
Known history or suspected cancer of the breast
Active or past history of venous thromboembolic events

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00205777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.