Osteoporosis, PostmenopausalPhase 3NCT00670501

Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

A Phase 3 study testing teriparatide, Calcium Supplement and Vitamin D Supplement in people with Osteoporosis, Postmenopausal, run by Eli Lilly and Company at 17 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to demonstrate a reduction in the proportion of new vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and vitamin D alone. Read more about this study

Who is it for?: Ages 30 to 85 years, women only
Conditions the study is for: Osteoporosis, Postmenopausal
What is being tested?: teriparatide, Calcium Supplement and Vitamin D Supplement
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,637 participants
Where: 17 sitesin 17 countries
Study dates: Aug 1996to Apr 1999
Phase: Phase 3
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 30 to 85 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Ambulatory, postmenopausal women.
A minimum of either one moderate or two mild atraumatic vertebral fractures, and a minimum of seven evaluable nonfractured vertebrae.
Hip BMD or lumbar spine BMD measurement at least 1.0 standard deviation (SD) below the average bone mass for young, healthy women (T-score) only in patients with fewer than two moderate fractures or in patients previously treated with therapeutic doses of bisphosphonates or fluorides
Normal or clinically nonsignificant abnormal laboratory values (serum calcium, PTH(1-84), \& urine calcium must be within normal limits at baseline; 25-hydroxyvitamin D must be between the lower limit of normal \& 3 times the upper limit of normal at baseline).

Who cannot join

Fractures in areas of bone affected by diseases other than osteoporosis (for example, cancer or Paget's disease).
Satisfactory baseline thoracic and lumbar spinal x-ray views cannot be obtained as determined by the centralized x-ray quality assurance center (for example, severe scoliosis or kyphosis).
Current or recent (within 1 year prior to randomization) metabolic bone disorders other than postmenopausal osteoporosis, such as Paget's disease, renal osteodystrophy, osteomalacia, or any secondary causes of osteoporosis
Current or recent (within 1 year prior to randomization) disease which affects bone metabolism, such as hypoparathyroidism, hyperparathyroidism, or hyperthyroidism.
Currently suspected carcinoma or history of carcinoma in the 5 years prior to randomization.
Nephrolithiasis or urolithiasis in the 2 years prior to randomization.

Show all 20Show fewer

Current or recent (within 1 year prior to randomization) sprue, inflammatory bowel disease, or malabsorption syndrome, or any indication of poor intestinal absorption of calcium, such as the combination of a low urinary calcium excretion and an elevated serum intact parathyroid hormone level.
Poor medical or psychiatric risk for treatment with an investigational drug, in the opinion of the investigator.
Treatment with androgens or other anabolic steroids in the 6 months prior to randomization.
Treatment with calcitonins in the 2 months prior to randomization.
Treatment with estrogen
Treatment with progestins in the 3 calendar months prior to randomization, or for more than 2 months in the 12 calendar months prior to randomization.
Treatment with corticosteroids.
Treatment with fluorides in the 6 months prior to randomization or for more than 60 days in the 24 months prior to randomization.
Treatment with oral bisphosphonates in the 3 months prior to randomization or for more than 60 days in the 24 months prior to randomization; treatment with intravenous bisphosphonates in the 24 months prior to randomization.
Treatment with vitamin D >50,000 IU/week, or with any dose of calcitriol, analogs, or agonists in the 6 months prior to randomization. The 25-hydroxyvitamin D laboratory value at randomization must be between the lower limit of normal and three times the upper limit of normal.
Treatment with coumarins and indandione derivatives in the 3 months prior to randomization; treatment with heparins >10,000 U/day for more than 30 days in the 6 months prior to randomization.
Treatment with calcium- or aluminum-containing antacids
Treatment with any other drug known to affect bone metabolism in the 6 months prior to randomization.
Treatment with any investigational drug during the month prior to the calcium and vitamin D run-in phase. Treatment with investigational drugs in certain therapeutic classes during the month prior to the calcium \& vitamin D run-in phase.

Trial locations and contacts

17 sites in 17 countries.

Country

City, postcode or hospital

17 sites in 17 countries

United States1 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.
Boston, Massachusetts, 02114

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Argentina1 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.
Capital Federal

Other trials in Argentina

Australia1 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.
Nedlands

Other trials in Australia

Austria1 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.
Graz

Other trials in Austria

Belgium1 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.
Brussels

Other trials in Belgium

Canada1 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.
Calgary, Alberta

Other trials in Canada

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

Other trials in Czechia

Denmark1 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.
Aarhus

Other trials in Denmark

Finland1 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.
Kuopio

Other trials in Finland

Hungary1 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.
Szeged

Other trials in Hungary

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.
Tel HaShomer

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Italy1 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.
Arenzano

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Netherlands1 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.
Amsterdam

Other trials in Netherlands

New Zealand1 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.
Christchurch

Other trials in New Zealand

Norway1 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.
Kristiansand

Other trials in Norway

Poland1 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.
Warsaw

Other trials in Poland

Sweden1 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.
Uppsala

Other trials in Sweden

About this study

Official title: Effects of LY333334 in the Treatment of Postmenopausal Women With Osteoporosis

Conditions: Osteoporosis, Postmenopausal
Being tested: teriparatide, Placebo, Calcium Supplement, Vitamin D Supplement
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
Also called LY333334, Forteo, Forsteo
40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
teriparatideDrug
Also called LY333334, Forteo, Forsteo
20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
PlaceboDrug
Placebo for subcutaneous injection will be supplied in a prefilled injection device with a cartridge identical in appearance to the LY333334 device.
Calcium SupplementDrug
Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
Vitamin D SupplementDrug
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement

Study groups in NCT00670501
Study group	Role	What they receive
1	Experimental	LY333334 40 micrograms/day plus calcium and vitamin D Receives: Drug: teriparatide; Drug: Calcium Supplement; Drug: Vitamin D Supplement
2	Experimental	LY333334 20 micrograms/day plus calcium and vitamin D Receives: Drug: teriparatide; Drug: Calcium Supplement; Drug: Vitamin D Supplement
3	Placebo comparator	Placebo plus calcium and vitamin D Receives: Drug: Placebo; Drug: Calcium Supplement; Drug: Vitamin D Supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

To demonstrate a reduction in the proportion of patients with new vertebral fractures (by spinal x-ray) following 3-year treatment with 20 and 40 micrograms/day of LY333334 plus calcium and vitamin D compared with calcium and vitamin D alone.
Measured: Baseline, randomization, 24 , 36, and 60 months

Secondary outcomes (11)

To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on lumbar spine and hip BMD in postmenopausal women with osteoporosis
Measured: Lumbar Spine: Randomization -2wks, Randomization,( 3 & 6 months in a subset of pts), 12 , 18 , 24 , 36 , 48 & 60 months. Hip BMD: Randomization -2wks, Randomization, 12 , 24 , 36 , 48 & 60 months.
To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on total body and radial (forearm) BMD in postmenopausal women with osteoporosis at selected study sites
Measured: Randomization, 12, 24, 36, 48 and 60 months
To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on the rate of new vertebral fractures (by spinal x-ray) in postmenopausal women with osteoporosis.
Measured: Baseline, randomization, 24 months, 60 months
To establish the effect of treatment with LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, by x-ray on the proportion of subjects experiencing new nonvertebral fractures alone & new nonvertebral & vertebral fractures combined.
Measured: As clinically needed throughout the trial
To assess the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on height (via Harpenden stadiometer or other suitable stadiometer) in postmenopausal women with osteoporosis
Measured: Randomization, 12, 24, 36, 48, and 60 months
To determine the histomorphometric effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone by biopsy, on the iliac crest (bone formation & resorption, mineralization, and trabecular structure) in a subset of subjects.
Measured: Randomization, 12 and 24 months
To assess effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, on biochemical markers of bone formation & resorption (bone-specific alkaline phosphatase, PICP, urinary N-telopeptide, & urinary free deoxypyridinolines)
Measured: Randomization, 1, 3, 6, 12, 24, 36, 48, and 60 months
To assess population pharmacokinetics of LY333334 at selected study sites. Nonlinear mixed effect modeling [NONMEM])and or PTH(1-84) will be employed to evaluate serum concentrations of LY333334.
Measured: Months 1, 3, 6, 12, 18, 24, 30, 36 and 60
To quantify medical resources used by patients during the study so that a cost-effectiveness analysis can be performed.
Measured: Randomization, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 Months
To assess the impact of LY333334 on health-related quality of life in postmenopausal women with osteoporosis. Quality of life instruments will be completed where translated and validated instruments are available.
Measured: Randomization, 12, 24, 36, 48, and 60 months
To establish the safety of chronic administration of LY333334 in postmenopausal women with osteoporosis. Adverse events, physical examinations and laboratory tests will be used to assess safety in the patients.
Measured: Adverse Events: throughout the trial. Labs:Baseline, randomization, 1, 6, 12, 24, 36, 48, and 60 months. Physical Exams: 12, 24, 36, 48, and 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 1996Apr 1999

First posted1 May 2008 (estimated)
Study startAug 1996
Primary completionApr 1999
Study completionApr 1999

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Osteoporosis, PostmenopausalStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1,637 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00670501
Sponsor's protocol ID: 547
Other IDs: B3D-MC-GHAC
Status last verified: Apr 2008
First submitted: 29 Apr 2008
Last updated: 1 May 2008
Results posted: No
Data monitoring committee: Yes

Publications

Prevrhal S, Krege JH, Chen P, Genant H, Black DM. Teriparatide vertebral fracture risk reduction determined by quantitative and qualitative radiographic assessment. Curr Med Res Opin. 2009 Apr;25(4):921-8. doi: 10.1185/03007990902790993.
PubMed 19250060

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoporosis, Postmenopausal trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of LY333334 in the Treatment of Postmenopausal Women With Osteoporosis
ClinicalTrials.gov ID: NCT00670501
Acronym / sponsor ID: 547
Conditions: Osteoporosis, Postmenopausal
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,637 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Aug 1996
Primary completion: Apr 1999 (actual)
Study completion: Apr 1999 (actual)
First posted: 1 May 2008 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: teriparatide, Drug: Calcium Supplement, Drug: Vitamin D SupplementLY333334 40 micrograms/day plus calcium and vitamin D
2	Experimental	Drug: teriparatide, Drug: Calcium Supplement, Drug: Vitamin D SupplementLY333334 20 micrograms/day plus calcium and vitamin D
3	Placebo comparator	Drug: Placebo, Drug: Calcium Supplement, Drug: Vitamin D SupplementPlacebo plus calcium and vitamin D

Who may qualify

Ages: 30 to 85 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Ambulatory, postmenopausal women.
A minimum of either one moderate or two mild atraumatic vertebral fractures, and a minimum of seven evaluable nonfractured vertebrae.
Hip BMD or lumbar spine BMD measurement at least 1.0 standard deviation (SD) below the average bone mass for young, healthy women (T-score) only in patients with fewer than two moderate fractures or in patients previously treated with therapeutic doses of bisphosphonates or fluorides
Normal or clinically nonsignificant abnormal laboratory values (serum calcium, PTH(1-84), \& urine calcium must be within normal limits at baseline; 25-hydroxyvitamin D must be between the lower limit of normal \& 3 times the upper limit of normal at baseline).

Key exclusion criteria (20 listed)

Fractures in areas of bone affected by diseases other than osteoporosis (for example, cancer or Paget's disease).
Satisfactory baseline thoracic and lumbar spinal x-ray views cannot be obtained as determined by the centralized x-ray quality assurance center (for example, severe scoliosis or kyphosis).
Current or recent (within 1 year prior to randomization) metabolic bone disorders other than postmenopausal osteoporosis, such as Paget's disease, renal osteodystrophy, osteomalacia, or any secondary causes of osteoporosis
Current or recent (within 1 year prior to randomization) disease which affects bone metabolism, such as hypoparathyroidism, hyperparathyroidism, or hyperthyroidism.
Currently suspected carcinoma or history of carcinoma in the 5 years prior to randomization.

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
teriparatideAlso: LY333334, Forteo, Forsteo40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase	Drug	1
teriparatideAlso: LY333334, Forteo, Forsteo20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase	Drug	2
PlaceboPlacebo for subcutaneous injection will be supplied in a prefilled injection device with a cartridge identical in appearance to the LY333334 device.	Drug	3
Calcium SupplementApproximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement	Drug	1, 2, 3
Vitamin D SupplementApproximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement	Drug	1, 2, 3

Primary outcome

To demonstrate a reduction in the proportion of patients with new vertebral fractures (by spinal x-ray) following 3-year treatment with 20 and 40 micrograms/day of LY333334 plus calcium and vitamin D compared with calcium and vitamin D alone.
Time frame: Baseline, randomization, 24 , 36, and 60 months

11 secondary outcomes

To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on lumbar spine and hip BMD in postmenopausal women with osteoporosis
Time frame: Lumbar Spine: Randomization -2wks, Randomization,( 3 & 6 months in a subset of pts), 12 , 18 , 24 , 36 , 48 & 60 months. Hip BMD: Randomization -2wks, Randomization, 12 , 24 , 36 , 48 & 60 months.
To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on total body and radial (forearm) BMD in postmenopausal women with osteoporosis at selected study sites
Time frame: Randomization, 12, 24, 36, 48 and 60 months
To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on the rate of new vertebral fractures (by spinal x-ray) in postmenopausal women with osteoporosis.
Time frame: Baseline, randomization, 24 months, 60 months
To establish the effect of treatment with LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, by x-ray on the proportion of subjects experiencing new nonvertebral fractures alone & new nonvertebral & vertebral fractures combined.
Time frame: As clinically needed throughout the trial
To assess the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on height (via Harpenden stadiometer or other suitable stadiometer) in postmenopausal women with osteoporosis
Time frame: Randomization, 12, 24, 36, 48, and 60 months
To determine the histomorphometric effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone by biopsy, on the iliac crest (bone formation & resorption, mineralization, and trabecular structure) in a subset of subjects.
Time frame: Randomization, 12 and 24 months
To assess effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, on biochemical markers of bone formation & resorption (bone-specific alkaline phosphatase, PICP, urinary N-telopeptide, & urinary free deoxypyridinolines)
Time frame: Randomization, 1, 3, 6, 12, 24, 36, 48, and 60 months
To assess population pharmacokinetics of LY333334 at selected study sites. Nonlinear mixed effect modeling [NONMEM])and or PTH(1-84) will be employed to evaluate serum concentrations of LY333334.
Time frame: Months 1, 3, 6, 12, 18, 24, 30, 36 and 60
To quantify medical resources used by patients during the study so that a cost-effectiveness analysis can be performed.
Time frame: Randomization, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 Months
To assess the impact of LY333334 on health-related quality of life in postmenopausal women with osteoporosis. Quality of life instruments will be completed where translated and validated instruments are available.
Time frame: Randomization, 12, 24, 36, 48, and 60 months
To establish the safety of chronic administration of LY333334 in postmenopausal women with osteoporosis. Adverse events, physical examinations and laboratory tests will be used to assess safety in the patients.
Time frame: Adverse Events: throughout the trial. Labs:Baseline, randomization, 1, 6, 12, 24, 36, 48, and 60 months. Physical Exams: 12, 24, 36, 48, and 60 months

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 1 May 2008.
Derived from this study: PubMed 19250060Prevrhal S, Krege JH, Chen P, Genant H, Black DM. Teriparatide vertebral fracture risk reduction determined by quantitative and qualitative radiographic assessment. Curr Med Res Opin. 2009 Apr;25(4):921-8. doi: 10.1185/03007990902790993.

Related trials for Osteoporosis, Postmenopausal

Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
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Romosozumab and Denosumab Combination Therapy for 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-CT LILLY (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

17 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing teriparatide, Calcium Supplement and Vitamin D Supplement in people with Osteoporosis, Postmenopausal, run by Eli Lilly and Company at 17 sites in 17 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 4 inclusion and 20 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 1 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Argentina, Australia, Austria, Belgium and 12 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

To demonstrate a reduction in the proportion of patients with new vertebral fractures (by spinal x-ray) following 3-year treatment with 20 and 40 micrograms/day of LY333334 plus calcium and vitamin D compared with calcium and vitamin D alone. (time frame: Baseline, randomization, 24 , 36, and 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00670501, which also lists 1 linked publication.

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 1 May 2008.