Overview

Switching From Oral Bisphosphonates to Bazedoxifene to Evaluate Effects on Bone Mineral Density in Postmenopausal Women

Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
0
Participant gender:
Female
Summary
The aim of this study is see the changes in bone mineral density after discontinuation or stop the use of bisphosphonates and make the switch to bazedoxifene).
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Instituto Palacios
Collaborator:
Pfizer
Treatments:
Bazedoxifene
Calcium
Calcium, Dietary
Diphosphonates
Vitamin D
Vitamins
Criteria
Inclusion Criteria:

- Ambulatory postmenopausal women 55 years or older at screening

- Have received daily, weekly or monthly oral bisphosphonates at least for 3 years and
treatment change is indicated (not responses to bisphosphonates, for bad tolerability
or for the potential risk of side effects in a long term treatment with
bisphosphonates-indicated by Federal Drug Administration, European Medicines Agency.

- Subjects has stop bisphosphonates therapy no more than one month before screening
visit for subjects in daily or weekly bisphosphonates

- Subjects has stop bisphosphonates therapy no more than two months before screening
visit for subjects in monthly bisphosphonates

- Screening T-score at the lumbar spine ≤ -2.0 to -4.0 by Dual X ray Absorptiometry
(DXA) scan

- At least 2 lumbar vertebrae must be evaluable by DXA

- Al least one hip must be evaluable by DXA (for secondary objectives)

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 Estrogens 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 Venous Thromboembolism Event (VTE)

- Significantly impaired renal function as determined by estimated Glomerular Filtration
Rate less 35 mL/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