OsteoporosisNCT00361595
Intervenous (IV) Zoledronic Acid After Forteo in Postmenopausal Women
A study testing zoledronic acid in people with Osteoporosis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the adequacy of zoledronic acid in maintaining bone mass after two years of treatment with Forteo, in postmenopausal women. Read more about this study
- Who is it for?
- Ages Up to 85 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Apr 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 85 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal women to age 85, inclusive
- Finish treatment of 12 months or longer with Forteo
- Signed informed consent prior to initiation of any study-mandated procedure.
Who cannot join
- Hip and spine DXA T-score >-1.0
- Patients with 25-(OH) vitamin D levels less than 15 ng/mL at Visit 1. (Patient can be repleted with vitamin D 50,000 units biweekly for up to 2 months and re-screened anytime during the 2 months while continuing Forteo.)
- Baseline renal insufficiency (calculated creatinine clearance less than 40.0 mL/min (MDRD) at Visit 1 and/or Visit 2 or urine dipstick greater than or equal to 2+ protein without evidence of contamination or bacteriuria (may be repeated one time at least a week apart if there is suspicion of contamination). Patients with calculated creatinine clearance equal to or greater than 40.0 mL/min and less than 60.0 mL/min or serum creatinine greater than the upper limit of normal at Visit 1 must be retested between Visit 1 and 2. Patients with calculated creatinine clearance greater than 60.0 mL/min and serum creatinine within normal limits at Visit 1 do not require re-test.
- Patients who require re-test of creatinine clearance between Visit 1 and 2 will be excluded if there is an increase in serum creatinine greater than 0.5 mg/dL between Visit 1 and Visit 2.
- Serum calcium <8.5 or >11.0 mg/dl at Visit 1
- AST or ALT greater than twice the upper limit of normal
Show all 32Show fewer
- Serum alkaline phosphatase greater than 1.5 times the upper limit of normal (liver fraction)
- No history of retinopathy or nephropathy especially in the presence of uncontrollable IDDM with Hb1 AC > 10%
- Hypersensitivity to bisphosphonates
- Treatment with biphosphonates while on Forteo
- Prior treatment with i.v. biphosphonates
- Estrogen, calcitonin, raloxifene use prior to Forteo treatment are not exclusions, but concomitant therapy during with any bone agents during the trial will not be permitted
- Any prior use of strontium ranelate or sodium fluoride
- Chronic use of systemic corticosteroids (oral or i.v.) within the last year:
- NOTE: Use of corticosteroids in forms such as topical creams, nasal or inhaled formulations or those injected locally (intra-articularly) are NOT exclusionary.
- Prior exposure to anabolic steroids or growth hormone within 6 months prior to randomization
- Treatment with any investigational drug(s) and/or devices within 30 days prior to randomization.
- History of iritis or uveitis, except when secondary to trauma, and must have resolved for more than 2 years prior to randomization.
- Cancer exclusions:
- Patients with a new diagnosis or active treatment for any malignancy less than or equal to 12 months prior to Visit 1.
- Patients with evidence of any metastases on or prior to randomization, or with a history of metastases
- Subjects with evidence of paraneoplastic syndrome, especially those characterized by hypercalcemia during screening or by history
- Patients with the following may be included: basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, and Carcinoma in-situ (CIS) of the prostate (Stage I only) that has been surgically removed.
- Previous major solid organ or bone marrow transplant recipient or on a transplant waiting list
- Any disease of the spine that would preclude the proper acquisition of a lumbar spine DXA (L1-L4) e.g., implantable devices, scoliosis, ankylosing spondylitis, DJD. (Less than two lumbar spine vertebral bodies evaluable)
- Active primary hyperparathyroidism or hypoparathyroidism
- Subject with complete thyroidectomy
- Active hyperthyroidism
- Hypothyroidism not treated with adequate replacement therapy
- History of multiple myeloma or Paget's disease
- Patients with severe dental problems or current dental infections, or with recent or impending dental surgery within three months of dosing
- Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
About this study
Official title: Open Label Proof of Concept Study of IV Zoledronic Acid (ZA) 5 mg After Forteo in Postmenopausal Women
The purpose of this study is to evaluate the adequacy of zoledronic acid in maintaining bone mass after two years of treatment with Forteo, in postmenopausal women.
Read the detailed description
This will be a single center open label proof of concept study, recruiting subjects previously treated with Forteo for at least 12 months.
A screening period of 3 to 6 weeks will precede the treatment period. At the baseline visit, patients whose eligibility is confirmed will be treated with ZA and followed for 12 months. Safety and efficacy will be assessed at regular intervals (day one, day 10, month 2, month 6, month 9 and month 12). Renal safety will be assessed prior to the i.v. dose of study medication, day 10 after the i.v. dose of study medication and at 12 months. Bone density at the lumbar spine (L1-4) and total hip will be performed at 6 months and at the end of the 12 month treatment period. Biomarker analyses for secondary endpoint will be performed for at day 10, month 2, month 6, month 9 and month 12.
- Conditions
- Osteoporosis
- Being tested
- zoledronic acid
- Keywords
- osteoporosis, zoledronic acid, forteo
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acidDrug
Also called zometa
5 mg zoledronic acid administered in a single 15 minute IV
| Study group | Role | What they receive |
|---|---|---|
| open label | Experimental | 5 mg zoledronic acid in a single 15 minute IV Receives: Drug: zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lumbar Spine BMD (Bone Mineral Density) in g/cm^2 From Baseline to Month 12 Relative to Baseline as Measured by DXA (Dual-energy X-ray Absorptiometry)
Measured: Baseline and 12 months
Secondary outcomes (3)
Change in Bone Density (Grams/cm^2) at the Total Hip at 6 and 12 Months
Change in bone density (grams/cm^2) at the total hip at 6 and 12 months. 12 month reported based on usual interval for bone density follow-up in clinical practice.
Measured: 6 months and 12 months
Change in Serum C-telopeptide Type 1 Collagen (CTX) (at Day 10 and Months 2, 6, 9 and 12)
Change in serum c-telopeptide type 1 collagen (CTX) (at day 10 and months 2, 6, 9 and 12. 12 month values reported based on 12 month duraton of zolendronic acid effect.
Measured: 12 months
Change in Serum N-propeptide Type 1 Collagen (P1NP) (at Day 10 and Months 2, 6, 9 and 12)
Change in serum n-propeptide type 1 collagen (P1NP) (at day 10 and months 2, 6, 9 and 12. 12 month values reported based on 12 month duraton of zolendronic acid effect.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Chad Deal, M.D., The Cleveland Clinic
- Investigators
- Chad Deal, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361595
- Sponsor's protocol ID
- CZOL446HUS120
- Status last verified
- Mar 2017
- First submitted
- 4 Aug 2006
- Last updated
- 21 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Proof of Concept Study of IV Zoledronic Acid (ZA) 5 mg After Forteo in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00361595
- Acronym / sponsor ID
- CZOL446HUS120
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, zoledronic acid, forteo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Aug 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 8 Aug 2006 (estimated)
- Results
- Posted 14 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the adequacy of zoledronic acid in maintaining bone mass after two years of treatment with Forteo, in postmenopausal women.
Detailed description
This will be a single center open label proof of concept study, recruiting subjects previously treated with Forteo for at least 12 months.
A screening period of 3 to 6 weeks will precede the treatment period. At the baseline visit, patients whose eligibility is confirmed will be treated with ZA and followed for 12 months. Safety and efficacy will be assessed at regular intervals (day one, day 10, month 2, month 6, month 9 and month 12). Renal safety will be assessed prior to the i.v. dose of study medication, day 10 after the i.v. dose of study medication and at 12 months. Bone density at the lumbar spine (L1-4) and total hip will be performed at 6 months and at the end of the 12 month treatment period. Biomarker analyses for secondary endpoint will be performed for at day 10, month 2, month 6, month 9 and month 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label | Experimental | Drug: zoledronic acid5 mg zoledronic acid in a single 15 minute IV |
Who may qualify
- Ages
- Up to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal women to age 85, inclusive
- Finish treatment of 12 months or longer with Forteo
- Signed informed consent prior to initiation of any study-mandated procedure.
Key exclusion criteria (32 listed)
- Hip and spine DXA T-score >-1.0
- Patients with 25-(OH) vitamin D levels less than 15 ng/mL at Visit 1. (Patient can be repleted with vitamin D 50,000 units biweekly for up to 2 months and re-screened anytime during the 2 months while continuing Forteo.)
- Baseline renal insufficiency (calculated creatinine clearance less than 40.0 mL/min (MDRD) at Visit 1 and/or Visit 2 or urine dipstick greater than or equal to 2+ protein without evidence of contamination or bacteriuria (may be repeated one time at least a week apart if there is suspicion of contamination). Patients with calculated creatinine clearance equal to or greater than 40.0 mL/min and less than 60.0 mL/min or serum creatinine greater than the upper limit of normal at Visit 1 must be retested between Visit 1 and 2. Patients with calculated creatinine clearance greater than 60.0 mL/min and serum creatinine within normal limits at Visit 1 do not require re-test.
- Patients who require re-test of creatinine clearance between Visit 1 and 2 will be excluded if there is an increase in serum creatinine greater than 0.5 mg/dL between Visit 1 and Visit 2.
- Serum calcium <8.5 or >11.0 mg/dl at Visit 1
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 |
|---|---|---|
| zoledronic acidAlso: zometa5 mg zoledronic acid administered in a single 15 minute IV | Drug | open label |
Primary outcome
Change in Lumbar Spine BMD (Bone Mineral Density) in g/cm^2 From Baseline to Month 12 Relative to Baseline as Measured by DXA (Dual-energy X-ray Absorptiometry)
Time frame: Baseline and 12 months
3 secondary outcomes
Change in Bone Density (Grams/cm^2) at the Total Hip at 6 and 12 Months
Time frame: 6 months and 12 months
Change in Serum C-telopeptide Type 1 Collagen (CTX) (at Day 10 and Months 2, 6, 9 and 12)
Time frame: 12 months
Change in Serum N-propeptide Type 1 Collagen (P1NP) (at Day 10 and Months 2, 6, 9 and 12)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Chad Deal, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zoledronic acid in people with Osteoporosis, run by The Cleveland Clinic 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 32 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 21 Apr 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Lumbar Spine BMD (Bone Mineral Density) in g/cm^2 From Baseline to Month 12 Relative to Baseline as Measured by DXA (Dual-energy X-ray Absorptiometry) (time frame: Baseline and 12 months). 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 21 Apr 2017.