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Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women
This study is ongoing, but not recruiting participants.

First Received on June 22, 2009.   Last Updated on January 28, 2011   History of Changes
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00927186
  Purpose

The purpose of this study is to investigate how teriparatide or zoledronic acid affects the bone of postmenopausal osteoporotic women after 6 months of treatment as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis).


Condition Intervention Phase
Osteoporosis, Post-menopausal
Drug: Teriparatide
Drug: Zoledronic Acid
Phase IV

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Skeletal Histomorphometry in Patients on Teriparatide or Zoledronic Acid Therapy

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Mineralizing surface(MS/BS)in the cancellous compartment of iliac crest bone biopsies after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mineralizing surface(MS/BS) in the endocortical compartment of iliac crest bone biopsies after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Activation frequency (Ac.f)in the cancellous and endocortical compartments of iliac crest bone biopsies after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Bone formation rate (BFR) in the cancellous and endocortical compartments of iliac crest bone biopsies after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mineral apposition rate (MAR) in the cancellous and endocortical compartments of iliac crest bone biopsies after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Adjusted apposition rate (Aj.AR)in the cancellous and endocortical compartments of iliac crest bone biopsies after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Extent of single or double tetracycline labels per bone surface (sLS/BS),(dLS/BS)in the cancellous and endocortical compartments of iliac crest bone biopsies after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Single or double tetracycline labels, both single plus double tetracycline labels, or no tetracycline labels in the cancellous and endocortical compartments of iliac crest bone biopsies after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Average length of tetracycline double labels in the cancellous and endocortical compartments of iliac crest bone biopsies after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Standard static histomorphometric parameters in the cancellous and endocortical compartments of iliac crest bone biopsies after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in serum procollagen type I N-terminal propeptide (PINP) from baseline through 12 months [ Time Frame: Baseline, 1, 3, 6, 12 months ] [ Designated as safety issue: No ]
  • Change in serum carboxyterminal cross-linking telopeptide of type I collagen (CTX)from baseline through 12 months [ Time Frame: Baseline, 1, 3, 6, 12 months ] [ Designated as safety issue: No ]
  • Change in serum osteocalcin (OC) from baseline through 12 months [ Time Frame: Baseline, 1, 3, 6, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2009
Estimated Study Completion Date: May 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teriparatide Drug: Teriparatide
20 mcg subcutaneous injection per day for 12 months
Other Names:
  • LY333334
  • Forteo
  • Forsteo
Active Comparator: Zoledronic Acid Drug: Zoledronic Acid
5 mg intravenous (IV) infusion administered once during 1 year study

  Eligibility

Ages Eligible for Study:   55 Years to 89 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatory, postmenopausal women with osteoporosis (no vaginal bleeding for at least 2 years prior to trial entry)
  • Free of severe or chronically disabling conditions other than osteoporosis that will impair ability to complete the trial
  • Bone mineral density (BMD) T-score of at least -2.5 at the femoral neck, total hip, or lumbar spine (L1-L4, with at least 2 evaluable vertebrae), with or without atraumatic fracture or,
  • Bone mineral density (BMD) T-score of at least -1.5 at the femoral neck, or total hip, or lumbar spine (L1-L4, with at least 2 evaluable vertebrae), and either 1 or more atraumatic vertebral fracture(s) or an atraumatic nonvertebral fracture in the opinion of the investigator. Nonvertebral fracture sites allowed are wrist, hip, pelvis, ribs,humerus,clavicle, leg (femur, tibia, and fibula, excluding the ankle).
  • Serum calcium, PTH, alkaline phosphatase must be within normal reference range

Exclusion Criteria:

  • Have an increased risk of osteosarcoma (bone tumor); this includes Paget's disease of bone, a previous bone tumor, or radiation involving the skeleton
  • Are allergic or cannot tolerate teriparatide or zoledronic acid or any of their ingredients or components
  • Are allergic to tetracycline
  • Have a history of exposure to tetracycline therapy in the 3 months prior to trial entry
  • Have participated in a prior parathyroid hormone (PTH) clinical trial or received prior treatment with teriparatide, PTH, or other related medications
  • Have a vitamin D level below 10 ng/ml
  • Have a condition that could possibly put one at risk for an adverse event due to the bone biopsy procedure (e.g. bleeding disorder)
  • Have undergone two previous iliac crest bone biopsies (one in each iliac crest)
  • Have taken any intravenous (IV) osteoporosis medication
  • Have taken other oral osteoporosis medications and have not been off of them for a specific period of time before trial entry
  • Have a history of certain cancers in the 5 years prior to trial entry
  • Have active liver disease
  • Have significantly impaired kidney function
  • Currently have active or suspected diseases that affect the bones, other than osteoporosis
  • Have active or recent history of significant gastrointestinal (stomach or intestinal) disorders
  • Have been treated with certain glucocorticoids for more than 30 days in the past 1 year prior to trial entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927186

Locations
United States, Colorado
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lakewood, Colorado, United States, 80227
United States, Georgia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Atlanta, Georgia, United States, 30319
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gainesville, Georgia, United States, 30501
United States, Maryland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bethesda, Maryland, United States, 20817
United States, Michigan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Detroit, Michigan, United States, 48202
United States, Nebraska
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Omaha, Nebraska, United States, 68131
United States, New Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Albuquerque, New Mexico, United States, 87106
United States, New York
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
West Haverstraw, New York, United States, 10993
United States, Wisconsin
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madison, Wisconsin, United States, 53705
Canada, Alberta
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vancouver, British Columbia, Canada, V6H 3X8
Canada, Quebec
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sainte-Foy, Quebec, Canada, G1V 3M7
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00927186     History of Changes
Other Study ID Numbers: 13032, B3D-US-GHDL
Study First Received: June 22, 2009
Last Updated: January 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Eli Lilly and Company:
osteoporosis
teriparatide
zoledronic acid
histomorphometry
bone biopsy
postmenopausal

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Zoledronic acid
Teriparatide
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012