OsteoporosisPhase 2NCT00668941
Cyclic Versus Daily Teriparatide on Bone Mass
A Phase 2 study testing Teriparatide, Alendronate and Calcium in people with Osteoporosis, run by Helen Hayes Hospital at 1 site in United States.
Trial summary
Osteoporosis is a disease that affects millions of individuals in the United States and abroad. It leads to decreased bone mass and causes an increased risk of fracture. This study will compare continuous versus cyclic treatment with teriparatide combined with alendronate, another drug for osteoporosis, or… Read more about this study
- Who is it for?
- Ages 45 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Teriparatide, Alendronate and Calcium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Nov 2017
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of osteoporosis or T score below -2 plus one or more osteoporosis related fractures
- Two measurable vertebrae between L1 and L4
- Willing to undergo a single iliac crest biopsy after administration of 4 tetracycline labels
Who cannot join
- Secondary causes of osteoporosis or presence of a skeletal disorder other than osteoporosis
- Uses drugs likely to affect skeletal or calcium homeostasis
- Multiple vertebral fractures or severe degenerative changes with fewer than two evaluable vertebrae
- Unwilling to undergo a single iliac crest biopsy
- History of allergy to tetracyclines, exposure to tetracyclines within the last year, or any remote long term use of tetracyclines
- Current use of anti-resorptive medicines (other than alendronate for half the female participants)
Show all 14Show fewer
- Use of hormone therapy, estrogen therapy, raloxifene, or calcitonin within 6 months before study entry
- Use of any bisphosphonate for more than 3 months within 2 years before study entry (only applies to participants in Groups 4, 5, and 6)
- History of a kidney stone within 5 years before study entry or any history of multiple kidney stones
- Hypercalcemia, hypercalciuria, or elevated parathyroid hormone (reduced 25-hydroxyvitamin D will be corrected prior to admission)
- Esophageal ulceration or stricture or known hypersensitivity to bisphosphonates
- History of external radiation therapy
- Unlikely or unable to complete the study, as determined by the investigators
- Illicit drug use or excessive alcohol consumption
Trial locations and contacts
1 site in 1 country.
United States1 site
Helen Hayes Hospital
West Haverstraw, New York, 10993
About this study
Osteoporosis is a disease that affects millions of individuals in the United States and abroad. It leads to decreased bone mass and causes an increased risk of fracture. This study will compare continuous versus cyclic treatment with teriparatide combined with alendronate, another drug for osteoporosis, or teriparatide alone in women with osteoporosis.
Read the detailed description
Osteoporosis is a serious bone disease that has become an important public health problem. It causes significant loss of bone mass and increases the risk of both fracture and architectural problems with the skeleton. Until recently, the treatments available for osteoporosis primarily prevented further deterioration of bone by reducing the rate of remodeling within the skeleton. This can reduce the risk of fracture by approximately 50%. Teriparatide is a new type of drug for people with osteoporosis who are at high risk of fracture. Teriparatide stimulates bone remodeling and can correct the underlying architectural and bone mass abnormalities that are characteristic of osteoporosis. This study will compare continuous versus cyclic treatment with teriparatide combined with alendronate, another drug for osteoporosis, or teriparatide alone in women with osteoporosis.
All participants have completed a parent study of two years that included a screening visit with a physical exam, blood draw, x-rays, EKG, and distribution of calcium and vitamin D supplements. Participants will be separated into two groups according to the treatment they have undergone over the year prior to study entry. Participants who have taken alendronate for at least 1 year prior to study entry will be assigned to Protocol 1. Participants who have not previously taken alendronate will be assigned to Protocol 2. Participants in both protocols will be randomly assigned to one of the following three biopsy groups: pre-treatment; early; or late. Participants in the pre-treatment biopsy group will have a bone biopsy before treatment begins. Those participants in the early biopsy group will have a biopsy at Week 7 of treatment, and those in the late group will have a biopsy at Month 7.5 of treatment.
Participants will also be randomly assigned to one of three treatment schedules. Participants in Protocol 1 may be assigned to receive alendronate alone for 24 months; teriparatide daily plus alendronate for 24 months; or teriparatide daily on and off for 3 months at a time plus alendronate for 24 months. Participants in Protocol 2 may be assigned to receive only the supplements they were given during the screening visit; teriparatide daily plus alendronate for 24 months; or teriparatide daily on and off for 3 months at a time for 24 months. Participants will attend assessment visits at Weeks 4 and 7 and Months 3, 5, 6, 7.5, 9, 12, 15, 18, 21, and 24. Visits may include bone turnover measurements, bone mass scans, walking tests, questionnaires, CT scans, and blood draws.
A recently funded extension study will extend the treatment period from 24 to 48 months for all consenting. If the individual was assigned to teriparatide daily (with or without alendronate), they will be given alendronate for the 24 to 48 month time period. If the individual was assigned to cyclic teriparatide, they will continue cyclic therapy foro the 24-48 month period (with or without alendronate).
- Conditions
- Osteoporosis
- Being tested
- Teriparatide, Alendronate, Calcium, Vitamin D3
- Keywords
- Bone Density, Bone Turnover, Histomorphometry
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Teriparatide will be given subcutaneously in 20-mcg doses either continuously or cyclically.
AlendronateDrug
Participants will take 70 mg per week of alendronate for 48 months.
CalciumDietary supplement
Calcium supplements will be administered in varied amounts for all participants, but each participant will take enough to bring her total daily calcium intake to 1,200 mg.
Vitamin D3Dietary supplement
Vitamin D3 supplements will be administered in varied amounts for all participants, but each participant will take enough to bring her total daily intake to 1,200 mg.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants in this group will have been treated with alendronate for at least 1 year prior to study entry. Upon study entry, they will receive a continuous regimen of daily teriparatide (20 mcg subcutaneously) for 48 months, in addition to alendronate. Biopsies will be performed at Week 7 or Month 7.5. The participants will then have the option to be followed while taking alendronate alone for 24-48 months. Receives: Drug: Teriparatide; Drug: Alendronate; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D3 |
| 2 | Experimental | Participants in this group will have been treated with alendronate for at least 1 year prior to study entry. Upon study entry, they will receive a cyclical regimen of teriparatide, in addition to alendronate. Teriparatide will be administered subcutaneously in 20-mcg doses daily for 3 months. They will receive no teriparatide for the following 3 months, and then teriparatide treatment will continue for the 3 months after that. This schedule will continue for 24 months with an aption to all participants to continue cyclic teriparatide for another 24 months. Biopsies will be performed at Week 7 or Month 7.5. Receives: Drug: Teriparatide; Drug: Alendronate; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D3 |
| 3 | Active comparator | Participants in this group will have been treated with alendronate for at least 1 year prior to study entry. Upon study entry, they will continue taking alendronate alone. Biopsies will be performed at Week 7 and then participants in this group will be offered teriparatide as part of Group 2 or 3. Receives: Drug: Alendronate; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D3 |
| 4 | Experimental | Participants in this group will receive a continuous regimen of teriparatide (20 mcg delivered subcutaneously) daily for 48 months. Biopsies will be performed at Week 7 or Month 7.5. At 24 months the participants will then have the option of taking alendronate and remaining in the study for another 24 months. Receives: Drug: Teriparatide; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D3 |
| 5 | Experimental | Participants in this group will receive a cyclical regimen of teriparatide. Teriparatide will be administered subcutaneously in 20-mcg doses daily for 3 months. They will receive no teriparatide for the following 3 months, and then teriparatide treatment will continue for the 3 months after that. This schedule will continue for 24 months with an option to all participants to continue cyclic teriparatide for another 24 months. Biopsies will be performed at Week 7 or Month 7.5. Receives: Drug: Teriparatide; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D3 |
| 6 | Active comparator | Participants in this group will take only calcium and vitamin D supplements. Biopsies will be performed at Week 7. Participants will then be offered the standard care for osteoporosis or they may enter the study in Group 4 or 5. Receives: Dietary Supplement: Calcium; Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density
Measured: 24 and 48 months
Secondary outcomes (2)
Histomorphometry of iliac crest bone biopsies
Measured: Measured at Week 7 and Month 7
HRpQCT (tibia, radius) and QCT (spine and hip)and FEA of these QCT scans
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startSep 2005
- Primary completionFeb 2016
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helen Hayes Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Health Research, Inc.
- Responsible party
- Principal investigator, Robert Lindsay, Helen Hayes Hospital
- Investigators
- Robert Lindsay, MD, PhD, Principal investigator, Helen Hayes Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668941
- Sponsor's protocol ID
- R01 AR056651-01A2, 5RO1 ARO5
- Other IDs
- R01AR056651-01A2
- Status last verified
- Aug 2017
- First submitted
- 27 Apr 2008
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ganapathy A, Nieves JW, Keaveny TM, Cosman F. Effects of four-year cyclic versus two-year daily teriparatide treatment on volumetric bone density and bone strength in postmenopausal women with osteoporosis. Bone. 2023 Feb;167:116618. doi: 10.1016/j.bone.2022.116618. Epub 2022 Nov 21.
PubMed 36410666Cosman F, Nieves JW, Roimisher C, Neubort S, McMahon DJ, Dempster DW, Lindsay R. Administration of teriparatide for four years cyclically compared to two years daily in treatment Naive and alendronate treated women. Bone. 2019 Mar;120:246-253. doi: 10.1016/j.bone.2018.10.020. Epub 2018 Oct 21.
PubMed 30355512
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclic Versus Daily Teriparatide on Bone Mass
- ClinicalTrials.gov ID
- NCT00668941
- Acronym / sponsor ID
- R01 AR056651-01A2, 5RO1 ARO5
- Conditions
- Osteoporosis
- Keywords
- Bone Density, Bone Turnover, Histomorphometry
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Helen Hayes HospitalUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Health Research, Inc.
- Study start
- Sep 2005
- Primary completion
- Feb 2016 (actual)
- Study completion
- Nov 2017 (estimated)
- First posted
- 29 Apr 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.
Osteoporosis is a disease that affects millions of individuals in the United States and abroad. It leads to decreased bone mass and causes an increased risk of fracture. This study will compare continuous versus cyclic treatment with teriparatide combined with alendronate, another drug for osteoporosis, or teriparatide alone in women with osteoporosis.
Detailed description
Osteoporosis is a serious bone disease that has become an important public health problem. It causes significant loss of bone mass and increases the risk of both fracture and architectural problems with the skeleton. Until recently, the treatments available for osteoporosis primarily prevented further deterioration of bone by reducing the rate of remodeling within the skeleton. This can reduce the risk of fracture by approximately 50%. Teriparatide is a new type of drug for people with osteoporosis who are at high risk of fracture. Teriparatide stimulates bone remodeling and can correct the underlying architectural and bone mass abnormalities that are characteristic of osteoporosis. This study will compare continuous versus cyclic treatment with teriparatide combined with alendronate, another drug for osteoporosis, or teriparatide alone in women with osteoporosis.
All participants have completed a parent study of two years that included a screening visit with a physical exam, blood draw, x-rays, EKG, and distribution of calcium and vitamin D supplements. Participants will be separated into two groups according to the treatment they have undergone over the year prior to study entry. Participants who have taken alendronate for at least 1 year prior to study entry will be assigned to Protocol 1. Participants who have not previously taken alendronate will be assigned to Protocol 2. Participants in both protocols will be randomly assigned to one of the following three biopsy groups: pre-treatment; early; or late. Participants in the pre-treatment biopsy group will have a bone biopsy before treatment begins. Those participants in the early biopsy group will have a biopsy at Week 7 of treatment, and those in the late group will have a biopsy at Month 7.5 of treatment.
Participants will also be randomly assigned to one of three treatment schedules. Participants in Protocol 1 may be assigned to receive alendronate alone for 24 months; teriparatide daily plus alendronate for 24 months; or teriparatide daily on and off for 3 months at a time plus alendronate for 24 months. Participants in Protocol 2 may be assigned to receive only the supplements they were given during the screening visit; teriparatide daily plus alendronate for 24 months; or teriparatide daily on and off for 3 months at a time for 24 months. Participants will attend assessment visits at Weeks 4 and 7 and Months 3, 5, 6, 7.5, 9, 12, 15, 18, 21, and 24. Visits may include bone turnover measurements, bone mass scans, walking tests, questionnaires, CT scans, and blood draws.
A recently funded extension study will extend the treatment period from 24 to 48 months for all consenting. If the individual was assigned to teriparatide daily (with or without alendronate), they will be given alendronate for the 24 to 48 month time period. If the individual was assigned to cyclic teriparatide, they will continue cyclic therapy foro the 24-48 month period (with or without alendronate).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Teriparatide, Drug: Alendronate, Dietary Supplement: Calcium, Dietary Supplement: Vitamin D3Participants in this group will have been treated with alendronate for at least 1 year prior to study entry. Upon study entry, they will receive a continuous regimen of daily teriparatide (20 mcg subcutaneously) for 48 months, in addition to alendronate. Biopsies will be performed at Week 7 or Month 7.5. The participants will then have the option to be followed while taking alendronate alone for 24-48 months. |
| 2 | Experimental | Drug: Teriparatide, Drug: Alendronate, Dietary Supplement: Calcium, Dietary Supplement: Vitamin D3Participants in this group will have been treated with alendronate for at least 1 year prior to study entry. Upon study entry, they will receive a cyclical regimen of teriparatide, in addition to alendronate. Teriparatide will be administered subcutaneously in 20-mcg doses daily for 3 months. They will receive no teriparatide for the following 3 months, and then teriparatide treatment will continue for the 3 months after that. This schedule will continue for 24 months with an aption to all participants to continue cyclic teriparatide for another 24 months. Biopsies will be performed at Week 7 or Month 7.5. |
| 3 | Active comparator | Drug: Alendronate, Dietary Supplement: Calcium, Dietary Supplement: Vitamin D3Participants in this group will have been treated with alendronate for at least 1 year prior to study entry. Upon study entry, they will continue taking alendronate alone. Biopsies will be performed at Week 7 and then participants in this group will be offered teriparatide as part of Group 2 or 3. |
| 4 | Experimental | Drug: Teriparatide, Dietary Supplement: Calcium, Dietary Supplement: Vitamin D3Participants in this group will receive a continuous regimen of teriparatide (20 mcg delivered subcutaneously) daily for 48 months. Biopsies will be performed at Week 7 or Month 7.5. At 24 months the participants will then have the option of taking alendronate and remaining in the study for another 24 months. |
| 5 | Experimental | Drug: Teriparatide, Dietary Supplement: Calcium, Dietary Supplement: Vitamin D3Participants in this group will receive a cyclical regimen of teriparatide. Teriparatide will be administered subcutaneously in 20-mcg doses daily for 3 months. They will receive no teriparatide for the following 3 months, and then teriparatide treatment will continue for the 3 months after that. This schedule will continue for 24 months with an option to all participants to continue cyclic teriparatide for another 24 months. Biopsies will be performed at Week 7 or Month 7.5. |
| 6 | Active comparator | Dietary Supplement: Calcium, Dietary Supplement: Vitamin D3Participants in this group will take only calcium and vitamin D supplements. Biopsies will be performed at Week 7. Participants will then be offered the standard care for osteoporosis or they may enter the study in Group 4 or 5. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of osteoporosis or T score below -2 plus one or more osteoporosis related fractures
- Two measurable vertebrae between L1 and L4
- Willing to undergo a single iliac crest biopsy after administration of 4 tetracycline labels
Key exclusion criteria (14 listed)
- Secondary causes of osteoporosis or presence of a skeletal disorder other than osteoporosis
- Uses drugs likely to affect skeletal or calcium homeostasis
- Multiple vertebral fractures or severe degenerative changes with fewer than two evaluable vertebrae
- Unwilling to undergo a single iliac crest biopsy
- History of allergy to tetracyclines, exposure to tetracyclines within the last year, or any remote long term use of tetracyclines
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 |
|---|---|---|
| TeriparatideTeriparatide will be given subcutaneously in 20-mcg doses either continuously or cyclically. | Drug | 1, 2, 4, 5 |
| AlendronateParticipants will take 70 mg per week of alendronate for 48 months. | Drug | 1, 2, 3 |
| CalciumCalcium supplements will be administered in varied amounts for all participants, but each participant will take enough to bring her total daily calcium intake to 1,200 mg. | Dietary supplement | 1, 2, 3, 4, 5, 6 |
| Vitamin D3Vitamin D3 supplements will be administered in varied amounts for all participants, but each participant will take enough to bring her total daily intake to 1,200 mg. | Dietary supplement | 1, 2, 3, 4, 5, 6 |
Primary outcome
Bone density
Time frame: 24 and 48 months
2 secondary outcomes
Histomorphometry of iliac crest bone biopsies
Time frame: Measured at Week 7 and Month 7
HRpQCT (tibia, radius) and QCT (spine and hip)and FEA of these QCT scans
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Derived from this study: PubMed 36410666Ganapathy A, Nieves JW, Keaveny TM, Cosman F. Effects of four-year cyclic versus two-year daily teriparatide treatment on volumetric bone density and bone strength in postmenopausal women with osteoporosis. Bone. 2023 Feb;167:116618. doi: 10.1016/j.bone.2022.116618. Epub 2022 Nov 21.
- Derived from this study: PubMed 30355512Cosman F, Nieves JW, Roimisher C, Neubort S, McMahon DJ, Dempster DW, Lindsay R. Administration of teriparatide for four years cyclically compared to two years daily in treatment Naive and alendronate treated women. Bone. 2019 Mar;120:246-253. doi: 10.1016/j.bone.2018.10.020. Epub 2018 Oct 21.
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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.
Robert Lindsay, MD, PhD principal investigator
Helen Hayes Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teriparatide, Alendronate and Calcium in people with Osteoporosis, run by Helen Hayes Hospital at 1 site in United States.
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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Bone density (time frame: 24 and 48 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 NCT00668941, which also lists 2 linked publications.
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 10 Aug 2017.