NCT02090400

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2013

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

2.2 years

First QC Date

March 11, 2014

Last Update Submit

September 8, 2015

Conditions

Osteoporosis, Postmenopausal

Keywords

WomenOsteoporosis, PostmenopausalBazedoxifeneBMD

Outcome Measures

Primary Outcomes (1)

  • Lumbar Spine Bone Mineral Density (BMD)

    To evaluate the change in Lumbar Spine Bone Mineral Density (BMD)

    12 months

Secondary Outcomes (4)

  • Bone Turnover Markers (BTM´s) carboxy-terminal collagen crosslinks (CTX) and 1 procollagen N-terminal (P1NP)

    6 and 12 months from baseline

  • BMD at the femoral neck

    6 and 12 months from baseline

  • BMD at total hip

    6 and 12 months from baseline

  • Mammography

    12 months from baseline

Other Outcomes (1)

  • Subject reported treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM) and gastrointestinal symptoms using the Gastrointestinal Symptoms Rating Scale (GSRS)the Spanish versions

    At baseline, months 6 and 12

Study Arms (2)

Bazedoxifene & Calcium/Vit D

OTHER

Bazedoxifene 20mg oral once a day and calcium 500mg and 400 IU vitamin D (OSTINE)

Drug: BazedoxifeneDrug: Calcium/Vit D

Calcium/Vit D

OTHER

Calcium 500mg and 400 IU vitamin D (OSTINE )daily.

Drug: Calcium/Vit D

Interventions

BazedoxifeneDRUG

20 mg Oral daily for 12 months

Also known as: Conbriza
Bazedoxifene & Calcium/Vit D
Calcium/Vit DDRUG

Calcium 500 mg / 400 IU Vit D

Also known as: Ostine
Bazedoxifene & Calcium/Vit DCalcium/Vit D

Eligibility Criteria

Age55 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Gabinete Médico Velázquez

Madrid, Madrid, 28001, Spain

Location

Instituto Palacios

Madrid, Madrid, 28009, Spain

Location

Instituto de Ginecología EGR

Madrid, Madrid, 28023, Spain

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

bazedoxifene

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Santiago Palacios, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 18, 2014

Study Start

May 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations

ES(3)