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Trial · Interventional

CompletedPhase 4Results postedRegistry data

µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis

Short name TERIZOL

NCTNCT01153425 (opens ClinicalTrials.gov in a new tab)Other id803763Other idR01AR041443

Overview

Status
Completed
Phase
Phase 4
Enrollment
33 participants (actual)
Sponsor
University of Pennsylvania · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jul 2008
Primary completion
Dec 2012
Completion
Dec 2012
First posted
30 Jun 2010 (estimated)
Last update posted
4 Aug 2017
Conditions
Osteoporosis, Osteopenia

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010201120122013
  1. Ph 4

    TERIZOL

    NCT01153425

    Jul 2008 to Dec 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to apply a novel advanced magnetic resonance imaging methodology to evaluate the response to drug intervention involving two treatment arms of postmenopausal participants with osteoporosis, randomized into either a teriparatide (Forteo™) or zoledronic acid (Reclast™) group.

Interventions

  • Virtual Bone BiopsyOther
  • TeriparatideDrug
  • Zoledronic AcidDrug

Arms2

  • Active comparator

    Teriparatide (Forteo)

    20 µg of Teriparatide will be self-injected subcutaneously once a day for 12 months and an MRI at 3T ('Virtual Bone Biopsy') will be performed at 0 and 12 months.

  • Active comparator

    Zoledronic Acid (Reclast)

    5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI at 3T ('Virtual Bone Biopsy) will be performed at 0 and 12 months.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Change in Trabecular Surface-to-curve Ratio

    Time frame · Change between baseline and 12 months

    Registry description

    Ratio of the volume densities of surface (S) and curve (C)-type voxels, S/C

Secondary outcomes(1)
  1. Percentage of Change in Bone Volume Fraction (BVF)

    Time frame · Change between baseline and 12 months

    Registry description

    Average fractional content of bone expressed in percent

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Change between baseline and 12 months

Percentage of Change in Trabecular Surface-to-curve Ratio

GroupValue (Percentage of Change)Spread
Teriparatide (Forteo)9.12.0
Zoledronic Acid (Reclast)7.12.6
Secondary and other outcome results(1)
Secondary outcomeMean· Change between baseline and 12 months

Percentage of Change in Bone Volume Fraction (BVF)

GroupValue (Percentage of Change)Spread
Teriparatide (Forteo)1.00.8
Zoledronic Acid (Reclast)0.60.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Teriparatide (Forteo)20 µg of teriparatide will be self-injected subcutaneously once a day for 24 months and an MRI ('Virtual Bone Biopsy') will be performed at 0 and 24 months. Virtual Bone Biopsy: MRI technology allowing generation of 3D images with considerably smaller voxel size than previous technology through the use of novel pulse sequences and advanced interpolation techniques. Teriparatide: Participants are clinically indicated for treatment.0 / 161 / 1615 / 16
Zoledronic Acid (Reclast)5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI ('Virtual Bone Biopsy) will be performed at 0 and 24 months. Virtual Bone Biopsy: MRI technology allowing generation of 3D images with considerably smaller voxel size than previous technology through the use of novel pulse sequences and advanced interpolation techniques. Zoledronic Acid: Participants are clinically indicated for treatment.0 / 170 / 1712 / 17

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Women * Age ≥ 60 years * Bone mineral density T-score of either the spine (L1-L4), total hip or femoral neck of ≤ - 2.0, or has a history of an osteoporotic fracture Exclusion Criteria: * Previous treatment with pamidronate, ibandronate, of more than 2 doses in 2 years and of zoledronic acid at any time * Previous treatment with teriparatide, alendronate or risedronate of more than 2 months in the last 24 months * Previous treatment with calcitonin within the previous year; previous treatment with an estrogen or selective estrogen modulator will not exclude a potential subject unless she has been taking it for \< 1 year (a woman who discontinued estrogen or a selective estrogen receptor within the previous year will also be excluded) * Other diseases known to affect bone, such as Paget's disease, Cushing's disease, hyperthyroidism, hyperparathyroidism, bone cancer and metastases to bone, and vitamin D deficiency * Medications known to affect bone, such as anticonvulsants, high dose glucocorticoids (20 mg/day or more \> 2 weeks within the previous 6 months) * Current alcohol use \> 3 drinks/day * Untreated or unstable cardiac, pulmonary, liver (SGOT \> 2X upper limit of normal) or renal disease (creatinine \> 1.2 mg/dL) or uncontrolled diabetes (hemoglobin A1C \> 8.0) * Prior radiation therapy to the skeleton * Cardiac pacemakers, ferromagnetic implants or brain aneurysm clips * Claustrophobia * Subjects whose initial MRI is of poor quality due to motion artifact will be asked to repeat the examination; if a repeat MRI is of poor quality due to motion artifact, the subject will be excluded from the study * Abnormalities of the which delay esophageal emptying such as stricture or achalasia * Inability to stand or sit upright for at least 30 minutes * Hypocalcemia * Uric acid level \>7.5ml/dl * Subjects with metallic objects in their bodies

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