µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis

NCT01153425 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 803763R01AR041443
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis, Osteopenia

Keywords

Osteoporosis; Osteopenia; Fracture Risk; teriparatide or Forteo; zoledronic acid or Reclast

Outcome Measures

Primary Outcomes (1)

• Percentage of Change in Trabecular Surface-to-curve Ratio

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

  Change between baseline and 12 months

Secondary Outcomes (1)

• Percentage of Change in Bone Volume Fraction (BVF)

  Change between baseline and 12 months

Study Arms (2)

Teriparatide (Forteo)

ACTIVE COMPARATOR

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.

Other: Virtual Bone Biopsy; Drug: Teriparatide

Zoledronic Acid (Reclast)

ACTIVE COMPARATOR

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.

Other: Virtual Bone Biopsy; Drug: Zoledronic Acid

Interventions

Virtual Bone Biopsy OTHER

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.

Also known as: VBB

Teriparatide (Forteo); Zoledronic Acid (Reclast)

Teriparatide DRUG

Participants are clinically indicated for treatment.

Also known as: Forteo

Teriparatide (Forteo)

Zoledronic Acid DRUG

Participants are clinically indicated for treatment.

Also known as: Reclast

Zoledronic Acid (Reclast)

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: Postmenopausal women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Eli Lilly and Company: collaborator
• Novartis Pharmaceuticals: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic

Interventions

Teriparatide; Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Insufficient Power

Results Point of Contact

• Title: Felix W. Wehrli, Ph.D.
• Organization: University of Pennsylvania, Perelman School of Medicine

wehrli@mail.med.upenn.edu

215-662-7951

Study Officials

• Felix W. Wehrli, Ph.D.

  University of Pennsylvania, Department of Radiology

  PRINCIPAL INVESTIGATOR

• Peter J. Snyder, M.D.

  University Of Pennsylvania, Department of Endocrinology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: Postmenopausal women, ages ≥ 60 years, indicated for treatment with antiresorptive or anabolic drugs due to severe osteoporosis and high risk of fracture.

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 30, 2010
• Study Start: July 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 4, 2017
• Results First Posted: August 4, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)