Skip to content

Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

PTH & Ibandronate Combination Study (PICS)

Short name PICS

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
44 participants (actual)
Sponsor
University of California, San Francisco · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
May 2008
Primary completion
Apr 2011
Completion
Apr 2011
First posted
23 May 2008 (estimated)
Last update posted
5 Nov 2013 (estimated)
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082009201020112012
  1. Ph 2/3

    PICS

    NCT00683163

    May 2008 to Apr 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • PTH(1-84)Drug
  • IbandronateDrug
  • Placebo injectionOther
  • Placebo pillsOther

Arms2

  • Active comparator

    A: 6 months both + 18 months oral only

    Group 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.

  • Active comparator

    B: (3 months injection + 9 months oral) x 2 years

    Group 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline, 3 months

    Registry description

    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.

Secondary outcomes(1)
  1. Change From Baseline in Trabecular Spine vBMD

    Time frame · Baseline, 24 months.

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· Baseline, 3 months

P1NP (ng/ml) Change From Baseline.

GroupValue (Percent change from baseline)
Concurrent (A)42
Sequential (B)186
Secondary and other outcome results(1)
Secondary outcomeMean· Baseline, 24 months.

Change From Baseline in Trabecular Spine vBMD

GroupValue (Percent change from baseline)Spread
Concurrent (A)12.511.2
Sequential (B)13.721.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Concurrent (A)Concurrent Group (A) received 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 were given months 13-15.–0 / 2221 / 22
Sequential (B)Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg followed by 9 months of monthly oral ibandronate 150 mg in each of years 1 and 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.–0 / 2221 / 22

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

More studies

2 studies on this page

Indexing hint: Randomized controlled trial · 2013

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).

Schafer et al. 2013Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USAcited by 22

PMID 23589163DOI 10.1007/s00198-013-2349-yPUB-23589163

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2012

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.

Schafer et al. 2012The Journal of clinical endocrinology and metabolismcited by 35

PMID 22791766PMC3674294DOI 10.1210/jc.2012-1844PUB-22791766

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
Female
Age
from 55 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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

PepBank is a research reference. Talk to a doctor before you use any peptide.