Postmenopausal OsteoporosisPhase 4NCT00239629
Teriparatide and Strontium Ranelate Head-To-Head Comparison Trial
A Phase 4 study testing Teriparatide, Strontium ranelate and Transiliac bone biopsy in people with Postmenopausal Osteoporosis, run by Eli Lilly and Company at 11 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 90 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Teriparatide, Strontium ranelate and Transiliac bone biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 73 participants
- Where
- 11 sitesin 6 countries
- Study dates
- Sep 2005to Jan 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Free of severe or chronically disabling conditions other than osteoporosis.
- 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.
- 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.
- 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.
- Normal or clinically insignificant abnormal laboratory values (as defined by the investigator) including serum calcium, PTH(1 84), alkaline phosphatase.
Who cannot join
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
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- Active liver disease or clinical jaundice.
- 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)]
- 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.
- 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.
- 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.
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
Germany4 sites
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
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
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
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
Greece2 sites
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
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
Spain2 sites
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
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
Czechia1 site
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
Israel1 site
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
Mexico1 site
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
About this study
Official title: Differential Effects of Teriparatide and Strontium Ranelate on Bone Remodeling and Formation in Postmenopausal Women With Osteoporosis
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.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Teriparatide, Strontium ranelate, Transiliac bone biopsy
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Strontium ranelateDrug
Transiliac bone biopsyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy measure is the mineralization surface (MS%BS) evaluated in double tetracycline stained bone biopsies.
Secondary outcomes (1)
Other routine histomorphometric parameters, measured at visits 2, 3, 4, and 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startSep 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239629
- Sponsor's protocol ID
- 10080
- Other IDs
- B3D-EW-GHCX
- Status last verified
- Jun 2007
- First submitted
- 13 Oct 2005
- Last updated
- 12 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of Teriparatide and Strontium Ranelate on Bone Remodeling and Formation in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT00239629
- Acronym / sponsor ID
- 10080
- Conditions
- Postmenopausal Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Jan 2007 (actual)
- First posted
- 17 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Free of severe or chronically disabling conditions other than osteoporosis.
- 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.
- 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.
- 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.
Key exclusion criteria (15 listed)
- 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.
- 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).
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teriparatide | Drug | – |
| Strontium ranelate | Drug | – |
| Transiliac bone biopsy | Procedure or surgery | – |
Primary outcome
The primary efficacy measure is the mineralization surface (MS%BS) evaluated in double tetracycline stained bone biopsies.
1 secondary outcome
Other routine histomorphometric parameters, measured at visits 2, 3, 4, and 5.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2007.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
Related trials for Postmenopausal Osteoporosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Eli Lilly and Company
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Teriparatide, Strontium ranelate and Transiliac bone biopsy in people with Postmenopausal Osteoporosis, run by Eli Lilly and Company at 11 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Greece, Spain, Czechia, Israel and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy measure is the mineralization surface (MS%BS) evaluated in double tetracycline stained bone biopsies.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2007.