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Teriparatide and Strontium Ranelate Head-To-Head Comparison Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00239629
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : June 12, 2007
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE October 13, 2005
First Posted Date  ICMJE October 17, 2005
Last Update Posted Date June 12, 2007
Study Start Date  ICMJE September 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2005)
The primary efficacy measure is the mineralization surface (MS%BS) evaluated in double tetracycline stained bone biopsies.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2005)
Other routine histomorphometric parameters, measured at visits 2, 3, 4, and 5.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Teriparatide and Strontium Ranelate Head-To-Head Comparison Trial
Official Title  ICMJE Differential Effects of Teriparatide and Strontium Ranelate on Bone Remodeling and Formation in Postmenopausal Women With Osteoporosis
Brief Summary The aim of this study is to directly compare the bone forming effects of 20 microg/day of teriparatide with those of 2 g/day strontium ranelate as measured by the histomorphometric variables and biochemical bone formation markers after 6 months of therapy in postmenopausal women with osteoporosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postmenopausal Osteoporosis
Intervention  ICMJE
  • Drug: Teriparatide
  • Drug: Strontium ranelate
  • Procedure: Transiliac bone biopsy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 13, 2005)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE


  1. Ambulatory, postmenopausal women aged 45 to 90 years inclusive at the time of entry into the trial, whose last menstrual period or bilateral oophorectomy occurred at least 5 years prior to entry into the trial. Women below the age of 55 years in whom a bilateral oophorectomy cannot clearly be documented must have their postmenopausal status confirmed by a serum FSH level greater or equal to 30 IU/L and serum estradiol level lower or equal to 20 pg/ml or lower or equal to 73 pmol/L.
  2. Free of severe or chronically disabling conditions other than osteoporosis.
  3. Able to use a pen-type injection delivery system satisfactorily in the opinion of the investigator and willing to be trained on and use the pen-injector on a daily basis.
  4. Without language barrier, cooperative, expected to return for all follow-up procedures, and have given informed consent after being informed of the risks, medications, and procedures to be used in the study.
  5. Posterior-anterior lumbar spine (L-1 through L-4) BMD and/or femoral neck BMD and/or total hip BMD measurement at least 2.5 standard deviations (SD) below the average bone mass for young women (T-score below or equal to -2.5 standard deviations). The lumbar spine and hip BMD assessment and the determination of the patient's eligibility for entry into the screening phase will be made by the individual investigator. Any lumbar vertebra that cannot be analyzed due to artifacts, severe crush fracture, osteophytes, or other abnormalities, should be excluded from the analysis. A minimum of two lumbar vertebrae in the L-1 through L-4 region must be evaluable by DXA if this is the only anatomical site where the BMD cut-off level less than -2.5 SD is demonstrated. A DXA assessment performed within three months prior to Visit 1 may be acceptable for patient's eligibility.
  6. Normal or clinically insignificant abnormal laboratory values (as defined by the investigator) including serum calcium, PTH(1 84), alkaline phosphatase.


  7. History of unresolved skeletal diseases that affect bone metabolism other than postmenopausal osteoporosis including Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption.
  8. In the opinion of the investigator, have any medical or anatomical condition that potentially could put the patient at additional risk of an adverse event due to the biopsy procedure (for example, coagulation abnormality, anticoagulant medication, extreme obesity, etc).
  9. Have undergone two previous iliac bone biopsies (one in each iliac crest). Patients with one previous iliac bone biopsy are eligible provided that the new sample is obtained from the contralateral iliac crest.
  10. History of malignant neoplasms in the 5 years prior to Visit 1, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may be randomized.
  11. Increased baseline risk of osteosarcoma; this includes subjects with Paget's disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation, i.e. prior external beam or implant radiation therapy. As an elevation of serum skeletal alkaline phosphatase activity may indicate the presence of Paget's disease, an unexplained elevation of this enzyme activity will also be exclusionary.
  12. Abnormal thyroid function not corrected by therapy. Normal thyroid function may be documented by a normal TSH during the screening phase or a combination of clinical and biochemical parameters which, in the judgment of the investigator and the Lilly Clinical Research Physician, sufficiently establishes the presence of normal thyroid function.
  13. Active liver disease or clinical jaundice.
  14. Significantly impaired renal function as defined by either of the following criteria:

    • Serum creatinine that, in the opinion of the investigator, indicates significant renal impairment.
    • Measured or calculated endogenous creatinine clearance less than 30 mL/min using the following Cockcroft Gault formula for creatinine clearance (ClCr) for women:

    ClCr (mL/minute) = [[(140-age) x weight (kg)]x0.85] / [72 x serum Cr (mg/dL)]

  15. Current or past treatment with any bisphosphonate, parathyroid hormone or its analogs, androgens or other anabolic steroids or therapeutic doses of fluorides at any time prior to Visit 2.

    Past treatment (more than 12 months before Visit 2) with a selective estrogen receptor modulator (SERM), nasal or injectable calcitonin, oral, transdermal, or injectable estrogens, progestins, estrogen analogs, estrogen agonists, estrogen antagonists or tibolone is allowed. Previous or current use of fluoridated water or topical dental fluoride treatments are permitted.

  16. Treatment with Vitamin D greater than 50,000 IU/week, or with any dose of calcitriol or Vitamin D analogs or agonists in the 6 months prior to Visit 2.
  17. Treatment with systemic corticosteroids in the last month prior to Visit 2 or for more than 14 days in the 1 year prior to Visit 2. Ophthalmic, otic, topical, orally inhaled, nasally inhaled, or intra-articular corticosteroid therapy may be used without these restrictions. However, orally inhaled or nasally inhaled corticosteroids in doses greater than 840 micrograms/day beclomethasone dipropionate or equivalent for more than 14 days in the last year prior to randomization will be disqualifying.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Germany,   Greece,   Israel,   Mexico,   Spain
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00239629
Other Study ID Numbers  ICMJE 10080
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP