Teriparatide and Strontium Ranelate Head-To-Head Comparison Trial
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopausal Osteoporosis
Intervention: Teriparatide (Drug); Strontium ranelate (Drug); Transiliac bone biopsy (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): 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), Study Director, Affiliation: Eli Lilly and Company
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.
Clinical Details
Official title: Differential Effects of Teriparatide and Strontium Ranelate on Bone Remodeling and Formation in Postmenopausal Women With Osteoporosis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The primary efficacy measure is the mineralization surface (MS%BS) evaluated in double tetracycline stained bone biopsies.
Secondary outcome: Other routine histomorphometric parameters, measured at visits 2, 3, 4, and 5.
Eligibility
Minimum age: 45 Years.
Maximum age: 90 Years.
Gender(s): Female.
Criteria:
INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
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.
Locations and Contacts
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., Prague 128 21, Czech Republic
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., Hamburg 20354, Germany
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., Heidelberg 69120, Germany
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., Magdeburg D-39110, Germany
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., Vogelsang 39245, Germany
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., Kifissia 145 61, Greece
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., Thessaloniki 56429, Greece
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., Haifa 31096, Israel
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., Guadalajara 44670, 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., Barcelona 08025, Spain
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., Madrid 28041, Spain
Additional Information
Lilly Clinical Trial Registry
Starting date: September 2005
Last updated: June 11, 2007
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