Ambulatory postmenopausal women with low BMD in general good health MedDRA version: 14.1 Level: LLT Classification code 10031289 Term: Osteoporosis, unspecified System Organ Class: 100000004859
Conditions
Interventions
Trade Name: CONBRIZA
Product Name: CONBRIZA
Pharmaceutical Form: Tablet
INN or Proposed INN: BAZEDOXIFENE ACETATE
CAS Number: 198481-33-3
Current Sponsor code: BAZEDOXIFENE ACETATE
Other descriptive n
Sponsors
Instituto Palacios
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Provide signed informed consent before any study procedures are conducted Ambulatory postmenopausal women 55 years or older at screening Have received daily, weekly or monthly oral bisphosphonates at least for 3 years Subjects has stop bisphosphonates therapy at least one month before screening visit for subjects in daily or weekly bisphosphonates Subjects has stop bisphosphonates therapy at least two months before screening visit for subjects in monthly bisphosphonates Screening Tscore at the lumbar spine ? -2.0 to -4.0 by DXA scan At least 2 lumbar vertebrae must be evaluable by DXA Al least one hip must be evaluable by DXA (for secondary objectives) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures Current use of medication prescribed for osteoporosis other than oral bisphosphonates Subjects who had received intravenous bisphosphonates or fluoride (except for dental treatment) Subjects who had received any Selective Estrogen Receptor Modulator (SERM), anabolic steroids, systemic hormone replacement, calcitonin or calcitriol within 3 months. Subjects who had received strontium ranelate, parathyroid hormone (PTH) or PTH derivates within 1 year. Hyper or hypothyroidism, current hyper or hypoparathyroidism History of VTE Significantly impaired renal function as determined by estimated Glomerular Filtration Rate less 35mL/min Hyper or hypocalcemia Vitamin D deficiency (serum 25 (OH) vit D level < 20 ng/mL (< 50nmol/L) Any condition that could result in impaired calcium metabolism or metabolic bone disease that could interfere with interpretation findings Any laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results Known intolerance to calcium supplements Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma cervical or breast ductal carcinoma in situ) within the last 5 years Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial Any physical or psychiatric disorder which, in the opinion of the investigator will prevent the subject from completing the study or interfere with the interpretation of the study results Evidence of alcohol or substance-abuse within the last 12 months which the investigator believes would interfere with understanding or completing the stud
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the change in Lumbar Spine Bone Mineral Density (BMD) at 12 months in postmenopausal women switching from daily, weekly or monthly bisphosphonates therapy at least for 3 years to Conbriza® 20mg oral(Bazedoxifene) once a day and calcium 500mg and 400IU vitamin D compared to that in subjects maintaining to only calcium 500mg and 400IU vitamin D daily;Secondary Objective: To evaluate the effects of switching to Conbriza® 20mg in comparison with switching to calcium 500mg and 400IU vitamin D daily on: - BTM`s CTX and P1NP at 12 months from baseline - BMD at the femoral neck at 6 and 12 months from baseline - BMD at total hip at 6 and 12 months from baseline - Safety changes in Mammography at 12 months from baseline;Primary end point(s): To evaluate the change in Lumbar Spine Bone Mineral Density (BMD) at 12 months in postmenopausal women switching from daily, weekly or monthly bisphosphonates therapy to Conbriza® 20mg oral(Bazedoxifene) once a day and calcium 500mg and 400IU vitamin D compared to that in subjects switching to only calcium 500mg and 400IU vitamin D daily. To evaluate the effects of switching to Conbriza® 20mg in comparison with switching to calcium 500mg and 400IU vitamin D daily on BTM`s CTX and P1NP at 12 months from baseline To evaluate the effects of switching to Conbriza® 20mg in comparison with switching to calcium 500mg and 400IU vitamin D daily on Safety changes in Mammography at 12 months from baseline - To evaluate the effects of switching to Conbriza® 20mg in comparison with switching to calcium 500mg and 400IU vitamin D daily on BMD at the femoral neck at 6 and 12 months from baseline - To evaluate the effects of switching to Conbriza® 20mg in comparison with switching to calcium 500mg and 400IU vitamin D daily on BMD at total hip at 6 and 12 months from baseline - To evaluate the effects of switching to Conbriza® 20mg in comparison with switching to calcium 500mg and 400IU vitamin D daily on Subject reported trea | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none | — |
Countries
Spain
Contacts
Public ContactBegoña Navarro
TFS
Outcome results
None listed