OsteoporosisPhase 4FACTNCT02416271

The Forteo Alendronate Comparator Trial

A Phase 4 study testing Teriparatide, Alendronate and Calcium in people with Osteoporosis, run by Eli Lilly and Company at 20 sites in 4 countries.

Completed

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

Official record

Search all trials

Trial summary

The main purpose of this study is to evaluate the effects of teriparatide with those of alendronate on spine bone mineral density (BMD) and other osteoporosis factors in postmenopausal women with osteoporosis. Read more about this study

Who is it for?: Ages 45 to 85 years, women only
Conditions the study is for: Osteoporosis
What is being tested?: Teriparatide, Alendronate and Calcium
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: 203 participants
Where: 20 sitesin 4 countries
Study dates: Apr 2001to May 2003
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 85 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Postmenopausal women with osteoporosis.
Ambulatory, 5 years or more past menopause.
BMD T score between -2.5 and -4.0 at the lumbar spine or femoral neck.
Normal or clinically insignificant abnormal laboratory values, including serum calcium, parathyroid hormone (PTH) 1-84, 25-hydroxyvitamin D, and alkaline phosphatase.

Who cannot join

Prior treatment with PTH or a PTH analogue.
Treatment with bisphosphonates within 12 months, anabolic corticosteroids or calcitriol or vitamin D analogues or agonists within 6 months, estrogens or selective estrogen receptor modulators within 3 months, or calcitonin within 2 months; therapeutic doses of fluoride; systemic corticosteroid use within 1 month or for more than 30 days in the prior year; use of anticoagulants within 1 month.
History of diseases other than postmenopausal osteoporosis that affect bone metabolism.
History of an increased risk of osteosarcoma (ie, patients with Paget disease of bone, previous skeletal exposure to external beam radiotherapy, or previous malignant neoplasm involving the skeleton).
Malignant neoplasms within 5 years; carcinoma in situ of the uterine cervix within 1 year.
Nephrolithiasis or urolithiasis within 2 years, or impaired renal function.

Show all 10Show fewer

Abnormal uncorrected thyroid function.
Liver disease or clinical jaundice.
Alcohol or other drug abuse.
Poor medical or psychiatric risk for treatment.

Trial locations and contacts

20 sites in 4 countries.

Country

City, postcode or hospital

20 sites in 4 countries

United States15 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.
Arden Hills, Minnesota, 55126
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.
Chicago, Illinois, 60611
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.
Greenville, North Carolina, 27834
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.
Honolulu, Hawaii, 96814
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.
Indianapolis, Indiana, 46260
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, 80227
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.
Mobile, Alabama, 36693
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.
Morristown, New Jersey, 07960
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.
Pittsburgh, Pennsylvania, 15213
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.
Portland, Oregon, 97213
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.
Providence, Rhode Island, 02903
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.
Springfield, Illinois, 62704
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.
St Louis, Missouri, 63110
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.
Tustin, California, 92780
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 Boylston, Massachusetts, 01583

Other trials in United States

Brazil2 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.
Recife, 52051
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.
São Paulo, 040024

Other trials in Brazil

Mexico2 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.
Mexico City, 14000
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.
Mezzanine, 06100

Other trials in Mexico

Puerto Rico1 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.
San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: Teriparatide Compared With Alendronate on Spine Bone Mineral Density in Postmenopausal Women With Osteoporosis

Conditions: Osteoporosis
Being tested: Teriparatide, Alendronate, Calcium, Vitamin D, Placebo-Oral
Medical subject headings: Osteoporosis

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
Administered SC
AlendronateDrug
Administered orally
CalciumDietary supplement
Administered orally
Vitamin DDietary supplement
Administered orally
Placebo-OralDrug
Administered orally
Placebo-SCDrug
Administered SC

Study groups in NCT02416271
Study group	Role	What they receive
Teriparatide	Experimental	20 micrograms per day teriparatide subcutaneous (SC) injection plus oral placebo for 18 months. Receives: Drug: Teriparatide; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D; Drug: Placebo-Oral
Alendronate	Active comparator	10 milligrams/day alendronate orally plus SC injection placebo for 18 months. Receives: Drug: Alendronate; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D; Drug: Placebo-SC

What is being measured

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

Percent Change from Baseline to 18 Months in Lumbar Spine BMD
Measured: Baseline, 18 Months

Secondary outcomes (12)

Percent Change from Baseline in Lumbar Spine BMD
Measured: Baseline, 3 Months, 6 Months, 12 Months
Percent Change from Baseline in Total Hip and Femoral Neck BMD
Measured: Baseline, 12 Months, 18 Months
Percent Change from Baseline in Trabecular Volumetric BMD at the Lumbar Spine
Measured: Baseline, 6 Months, 18 Months
Percent Change from Baseline in Cortical BMD at the Femoral Neck
Measured: Baseline, 6 Months, 18 Months
Percent Change from Baseline in Trabecular BMD at the Femoral Neck
Measured: Baseline, 6 Months, 18 Months
Percent Change from Baseline in Biochemical Marker -Serum Procollagen I C-Terminal Propeptide (PICP)
Measured: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percent Change from Baseline in Biochemical Marker -Serum Procollagen I N-Terminal Propeptide (PINP)
Measured: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percent Change from Baseline in Biochemical Marker -Bone-Specific Alkaline Phosphatase (BSAP)
Measured: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percent Change from Baseline in Biochemical Marker -Urinary N-Telopeptide (NTX)
Measured: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percentage of Participants with Nonvertebral Fractures
Measured: 18 Months
Percentage of Participants with Clinical Fractures
Measured: 18 Months
Change from Baseline on the Back Pain Questionnaire
Measured: Baseline, 3 Months, 6 Months, 18 Months

Timeline

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

Apr 2001May 2003

First posted14 Apr 2015 (estimated)
Study startApr 2001
Primary completionMay 2003
Study completionMay 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 203 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02416271
Sponsor's protocol ID: 4943
Other IDs: B3D-MC-GHBM
Acronym: FACT
Status last verified: Apr 2015
First submitted: 9 Apr 2015
Last updated: 14 Apr 2015
Results posted: No
Data monitoring committee: Yes

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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Romosozumab and Denosumab Combination Therapy for Osteoporosis
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All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Teriparatide Compared With Alendronate on Spine Bone Mineral Density in Postmenopausal Women With Osteoporosis
ClinicalTrials.gov ID: NCT02416271
Acronym / sponsor ID: FACT / 4943
Conditions: Osteoporosis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 203 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2001
Primary completion: May 2003 (actual)
Study completion: May 2003 (actual)
First posted: 14 Apr 2015 (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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Teriparatide	Experimental	Drug: Teriparatide, Dietary Supplement: Calcium, Dietary Supplement: Vitamin D, Drug: Placebo-Oral20 micrograms per day teriparatide subcutaneous (SC) injection plus oral placebo for 18 months.
Alendronate	Active comparator	Drug: Alendronate, Dietary Supplement: Calcium, Dietary Supplement: Vitamin D, Drug: Placebo-SC10 milligrams/day alendronate orally plus SC injection placebo for 18 months.

Who may qualify

Ages: 45 to 85 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Postmenopausal women with osteoporosis.
Ambulatory, 5 years or more past menopause.
BMD T score between -2.5 and -4.0 at the lumbar spine or femoral neck.
Normal or clinically insignificant abnormal laboratory values, including serum calcium, parathyroid hormone (PTH) 1-84, 25-hydroxyvitamin D, and alkaline phosphatase.

Key exclusion criteria (10 listed)

Prior treatment with PTH or a PTH analogue.
Treatment with bisphosphonates within 12 months, anabolic corticosteroids or calcitriol or vitamin D analogues or agonists within 6 months, estrogens or selective estrogen receptor modulators within 3 months, or calcitonin within 2 months; therapeutic doses of fluoride; systemic corticosteroid use within 1 month or for more than 30 days in the prior year; use of anticoagulants within 1 month.
History of diseases other than postmenopausal osteoporosis that affect bone metabolism.
History of an increased risk of osteosarcoma (ie, patients with Paget disease of bone, previous skeletal exposure to external beam radiotherapy, or previous malignant neoplasm involving the skeleton).
Malignant neoplasms within 5 years; carcinoma in situ of the uterine cervix within 1 year.

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, ForsteoAdministered SC	Drug	Teriparatide
AlendronateAdministered orally	Drug	Alendronate
CalciumAdministered orally	Dietary supplement	Alendronate, Teriparatide
Vitamin DAdministered orally	Dietary supplement	Alendronate, Teriparatide
Placebo-OralAdministered orally	Drug	Teriparatide
Placebo-SCAdministered SC	Drug	Alendronate

Primary outcome

Percent Change from Baseline to 18 Months in Lumbar Spine BMD
Time frame: Baseline, 18 Months

12 secondary outcomes

Percent Change from Baseline in Lumbar Spine BMD
Time frame: Baseline, 3 Months, 6 Months, 12 Months
Percent Change from Baseline in Total Hip and Femoral Neck BMD
Time frame: Baseline, 12 Months, 18 Months
Percent Change from Baseline in Trabecular Volumetric BMD at the Lumbar Spine
Time frame: Baseline, 6 Months, 18 Months
Percent Change from Baseline in Cortical BMD at the Femoral Neck
Time frame: Baseline, 6 Months, 18 Months
Percent Change from Baseline in Trabecular BMD at the Femoral Neck
Time frame: Baseline, 6 Months, 18 Months
Percent Change from Baseline in Biochemical Marker -Serum Procollagen I C-Terminal Propeptide (PICP)
Time frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percent Change from Baseline in Biochemical Marker -Serum Procollagen I N-Terminal Propeptide (PINP)
Time frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percent Change from Baseline in Biochemical Marker -Bone-Specific Alkaline Phosphatase (BSAP)
Time frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percent Change from Baseline in Biochemical Marker -Urinary N-Telopeptide (NTX)
Time frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percentage of Participants with Nonvertebral Fractures
Time frame: 18 Months
Percentage of Participants with Clinical Fractures
Time frame: 18 Months
Change from Baseline on the Back Pain Questionnaire
Time frame: Baseline, 3 Months, 6 Months, 18 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 14 Apr 2015.

Related trials for Osteoporosis

Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
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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

20 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Teriparatide, Alendronate and Calcium in people with Osteoporosis, run by Eli Lilly and Company at 20 sites in 4 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 10 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 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Brazil, Mexico, Puerto Rico. 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?

Percent Change from Baseline to 18 Months in Lumbar Spine BMD (time frame: Baseline, 18 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 NCT02416271.

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 14 Apr 2015.