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OsteoporosisPhase 2/3PICSNCT00683163

PTH & Ibandronate Combination Study (PICS)

A Phase 2/3 study testing PTH(1-84) and Ibandronate in people with Osteoporosis, run by University of California, San Francisco at 1 site in United States.

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

This study will test in several innovative ways, several different combinations of PTH and oral monthly ibandronate for the treatment of osteoporosis in postmenopausal women. The intension is to provide other options for treatment than the current standard 2 year course of drug therapy. Read more about this study

Who is it for?
Ages 55 to 75 years, women only
Conditions the study is for
Osteoporosis
What is being tested?
PTH(1-84) and Ibandronate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteUnited States
Study dates
May 2008to Apr 2011
Phase
Phase 2/3
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 55 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female
  • Aged 55-75 years, inclusive, at randomization
  • Postmenopausal for >= 5 years (no menses for at least 5 years)
  • Have an evaluable bone mineral density scan (DXA) at the spine AND at the hip with a T-score <= -1.5 either at the spine or the femoral neck or total hip OR have a T-score <= -1.0 with at least one of the following risk factors for fracture: 1)Age >= 65 years; 2)History of post-menopausal fracture (non-vertebral or vertebral); 3)Maternal history of hip fracture.
  • Be willing and able to self-administer daily injections
  • Signed written consent form.

Who cannot join

  • History of more than 12 months of oral bisphosphonate use ever, or any use (>4 weeks) with the past 12 months. For those with 4 weeks to 12 months of previous use, a 24 month washout is required.
  • History of any IV bisphosphonate use.
  • History of more than 12 month of PTH use ever, or any use (>4 weeks) with the past 12 months.
  • History of estrogen (oral or patch) more than one month in the last 6 months or for more than 12 months in the last 2 years.
  • Have type 1 or uncontrolled type 2 diabetes mellitus (defined as hemoglobin A1C > 10.0), or currently using insulin.
  • Have serum calcium >10.2 mg/dl.
Show all 34Show fewer
  • Have Vitamin D level <15 nanograms/ml.
  • Have Stage III renal insufficiency where calculated creatinine clearance < 40 ml/min by MDRD.
  • Have any history of kidney stones in the last 10 years.
  • Have any history of hypercalcuria or currently have urine calcium >300 mg/24 hours.
  • Have any history of hypercalcemia.
  • Have any history of sarcoidosis.
  • Have any history of hyperparathyroidism.
  • Have any history of active or treated tuberculosis or other granulomatous disorders.
  • History of breast cancer, melanoma or hematologic malignancy which has required treatment within the last 10 years.
  • Any history of bone cancer or Paget's disease of bone
  • Any other metabolic bone disease which has required treatment within the last 10 years.
  • History of any other non-skin cancer which has required treatment within the last 10 years.
  • Have a documented history of symptomatic esophageal reflux, achalasia or esophageal stricture.
  • Be currently taking > 7.5 mg systemic prednisone or equivalent per day or for more than 10 days in the last 3 months.
  • Be currently using > 2 puffs, 4 times / day of inhaled steroids.
  • Be currently taking anticoagulants.
  • Be currently taking anticonvulsants that alter hepatic vitamin D clearance
  • Have used Calcitonin within the past 3 months.
  • Have used Raloxifene in the last 6 months or for more than 12 months in the last 2 years.
  • Have used Tamoxifen in the last 6 months or for more than 12 months in the last 2 years.
  • Have used fluoride for at least a month within the past 5 years.
  • Be currently taking > 1000 IU/day Vitamin D
  • Using Vitamin D analogues or metabolites.
  • Be currently taking thyroid hormone replacement AND have a TSH < 0.1mIU/L.
  • Have any major life-threatening illness.
  • Concurrent enrollment in another double-blinded clinical treatment intervention study.
  • Life expectancy less than 3 years
  • Willing to discontinue all over the counter nutritional supplements

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, San Francisco

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: PTH & Ibandronate Combination Study (PICS): Optimizing the Use of PTH With Boniva (Pilot Randomized Controlled Trial)

This study will test in several innovative ways, several different combinations of PTH and oral monthly ibandronate for the treatment of osteoporosis in postmenopausal women. The intension is to provide other options for treatment than the current standard 2 year course of drug therapy. These options may lead to treatment where the two years of therapy are spread over several years.

Read the detailed description

This randomized double-blind clinical trial for the treatment of postmenopausal osteoporosis will be conducted and coordinated by study investigators who also participated in the investigator-initiated PaTH study. Final data analysis will compare the results from this trial with those from the PaTH study. In the PaTH study, 238 women between 55 and 85 years of age were randomized to receive either:

  1. PTH for 1 year followed by alendronate for 1 year
  2. PTH and alendronate for 1 year followed by alendronate for 1 year
  3. alendronate for 2 years
  4. PTH for 1 year followed by placebo for 1 year.

In the PICS 44 postmenopausal women between the ages of 55 to 75 years of age with osteoporosis who meet the inclusion/exclusion criteria,will be randomized to the following 2 treatment groups. Group A will received 6 months of monthly Ibandronate, plus daily PTH 1-84,100 μg; followed by 18 months of Ibandronate only. Group B will received 3 months of daily PTH 1-84,100 μg; followed by 9 months of monthly Ibandronate, over 2 years. Calcium (400-650 mg) and Vitamin D (400 IU) supplements will be provided to all participants.

The primary objective is to determine if, at 3 months, the women treated with the concurrent combination of PTH and ibandronate (Group A) show a significant increase in bone marker formation compared to baseline (unlike the combination PTH/alendronate-treated women in PaTH). This will be accessed by examining the change in the markers P1NP, BSAP and serum CTX.

As a secondary objective, we will compare the trabecular spine BMD measures of those treated with concurrent PTH/Ibandronate (Group A) to those who received 3 months of PTH followed by Ibandronate(Group B). Another secondary objective will be to compare changes between groups in trabecular bone and DXA spine BMD after 2 years of treatment.

Changes to the fat content of the vertebrae during a course of PTH therapy will be examined using MRI spinal spectroscopy. Crosstabulation of these changes against changes in trabecular BMD, should indicate an effect on measurements. As well, the effect of a second three-month course of PTH therapy in Group B is of major interest.

Conditions
Osteoporosis
Being tested
PTH(1-84), Ibandronate, Placebo injection, Placebo pills
Keywords
Combination of PTH and ibandronate, Bone marker formation, Postmenopausal, Trabecular spine BMD
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PTH(1-84)Drug

    Also called In Europe, PTH(1-84) is marketed as Preotact.

    1.4 mg injected subcutaneously (in the abdomen) daily

  • IbandronateDrug

    Also called Boniva

    150mg by mouth once monthly

  • Placebo injectionOther

    Daily injections as placebo for PTS 1-84

  • Placebo pillsOther

    Monthly pills as placebo for oral ibandronate

Study groups in NCT00683163
Study groupRoleWhat they receive
A: 6 months both + 18 months oral onlyActive comparatorGroup A will receive 6 months of monthly oral ibandronate 150 mg, plus daily PTH 1-84, 1.4 mg; followed by 18 months of ibandronate only. Placebo injections will be given months 13-15. Calcium + Vitamin D supplements, plus multivitamins are provided.
Receives: Drug: PTH(1-84); Drug: Ibandronate; Other: Placebo injection
B: (3 months injection + 9 months oral) x 2 yearsActive comparatorGroup B will receive 3 months of daily PTH 1-84, 1.4 mg; followed by 9 months of monthly oral ibandronate, 150 mg in year 1. In year 2, the group will receive another 3 months of daily PTH 1-84; followed by 9 months of monthly ibandronate. Placebo monthly pills will be given months 1-3 and months 13-15, and placebo injections will be given months 4-6. Calcium + Vitamin D supplements, plus multivitamins are provided.
Receives: Drug: PTH(1-84); Drug: Ibandronate; Other: Placebo injection; Other: Placebo pills

What is being measured

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

  1. P1NP (ng/ml) Change From Baseline.

    After an overnight fast, serum was drawn at baseline and 1, 3, 6, 12, 15, 18 and 24 months. Samples were stored at -70C until batch assayed in a central laboratory. Serum N-propeptide of type I collagen (P1NP) and C-terminal telopeptide of type I collagen (CTX) were measured by electrochemiluminescent immunoassay. Bone-specified alkaline phosphate (BAP) was measured by paramagnetic particle immunoassay. P1NP was the bone turnover marker upon which we based sample size calculations.

    Measured: Baseline, 3 months

Secondary outcomes (1)

  1. Change From Baseline in Trabecular Spine vBMD

    Areal bone mineral density (aBMD) at the lumbar spine, hip, and distal one-third radius was assessed by dual-energy X-ray absorption at baseline and 6, 12, 18, and 24 months. The precision for aBMD is 1.0%. Volumetric BMD and bone geometry in trabecular and cortical compartments were assessed by quantitative computed tomography (QCT) at the spine and hip. The left hip was used for analysis. The precision for trabecular spine vBMD measurement is 1.0%. Trabecular spine vBMD was our primary BMD outcome, thus the one presented here.

    Measured: Baseline, 24 months.

Timeline

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

  1. First posted23 May 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionApr 2011
  4. Study completionApr 2011

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00683163
Sponsor's protocol ID
PICS001
Acronym
PICS
Status last verified
Aug 2013
First submitted
20 May 2008
Last updated
5 Nov 2013
Data monitoring committee
Yes

Publications

  • Li X, Kuo D, Schafer AL, Porzig A, Link TM, Black D, Schwartz AV. Quantification of vertebral bone marrow fat content using 3 Tesla MR spectroscopy: reproducibility, vertebral variation, and applications in osteoporosis. J Magn Reson Imaging. 2011 Apr;33(4):974-9. doi: 10.1002/jmri.22489.

    PubMed 21448966

  • Schafer AL, Burghardt AJ, Sellmeyer DE, Palermo L, Shoback DM, Majumdar S, Black DM. Postmenopausal women treated with combination parathyroid hormone (1-84) and ibandronate demonstrate different microstructural changes at the radius vs. tibia: the PTH and Ibandronate Combination Study (PICS). Osteoporos Int. 2013 Oct;24(10):2591-601. doi: 10.1007/s00198-013-2349-y. Epub 2013 Apr 16.

    PubMed 23589163

  • Schafer AL, Sellmeyer DE, Palermo L, Hietpas J, Eastell R, Shoback DM, Black DM. Six months of parathyroid Hormone (1-84) administered concurrently versus sequentially with monthly ibandronate over two years: the PTH and ibandronate combination study (PICS) randomized trial. J Clin Endocrinol Metab. 2012 Oct;97(10):3522-9. doi: 10.1210/jc.2012-1844. Epub 2012 Jul 12.

    PubMed 22791766

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing PTH(1-84) and Ibandronate in people with Osteoporosis, run by University of California, San Francisco 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 6 inclusion and 34 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 5 Nov 2013. 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 combined 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.

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?

Yes. Results are posted in the registry (first posted 5 Nov 2013). 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?

P1NP (ng/ml) Change From Baseline. (time frame: Baseline, 3 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 NCT00683163, which also lists 3 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 5 Nov 2013.

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PTH & Ibandronate Combination Study (PICS) | AzTrials