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