Trial · Interventional

TerminatedNot applicableResults postedRegistry data

Stem Cell Recruitment in Osteoporosis Therapy

NCTNCT01656629Other idNA_00050448

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Inability to analyze collected samples due to no funds.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Not applicable
Enrollment: 55 participants (actual)
Sponsor: Johns Hopkins University · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Aug 2012
Primary completion: Jun 2014
Completion: 7 Aug 2020
First posted: 3 Aug 2012 (estimated)
Last update posted: 21 Aug 2020
Conditions: Low Bone Density

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20122014201620182020

N/A
Stem Cell Recruitment in Osteoporosis Therapy
NCT01656629
Aug 2012 to 7 Aug 2020
Terminated
Terminated

Registry summary

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

Osteoporosis is an important health problem in the rapidly-aging demographic. Fragility fractures are devastating consequences of osteoporosis. The most common treatment approach in osteoporosis is inhibition of bone resorption with drugs like alendronate (ALN). Parathyroid hormone (PTH) stimulates bone formation and is the only anabolic drug available. Dual therapy with ALN and PTH is not as effective as single-drug therapy in preventing fracture. Bone progenitor cells (MSCs) are recruited to sites of bone remodeling when a growth factor called Transforming Growth Factor Beta (TGF-β1) is released from bone. Different osteoporosis medicines may have differing effects on this process. The effects of ALN versus PTH on bone progenitor recruitment in humans are unknown. This is a randomized, clinical trial of ALN, PTH, and calcium and vitamin D in post-menopausal women with low bone mass. Women will be treated for 3 months with ALN or PTH or calcium and vitamin D. Data collected will include bone biopsies for histomorphometry and micro computed tomography (µCT), bone marrow aspirates for molecular studies, peripheral blood to detect circulating bone progenitor cells and dual X-ray absorptiometry. The investigators hypothesize that in humans, PTH will 1) increase bone progenitor number, 2) enhance recruitment of bone progenitor cells to bone resorption sites, and 3) increase bone progenitor number in peripheral circulation. Furthermore, the investigators hypothesize that ALN treatment will have the opposite effect. Understanding the differences in bone progenitor cell activity and recruitment during osteoporosis therapy will provide a mechanistic rationale for effective use of PTH and anti-resorptive drugs in osteoporosis treatment.

Interventions

TeriparatideDrug
AlendronateDrug
calcium and vitamin DDietary supplement

Arms3

Active comparator
teriparatide
teriparatide 20 mcg sq for 3 months
Active comparator
Alendronate
70 mg po weekly for 3 months
Active comparator
calcium and vitamin D
calcium 630 mg vitamin D 500 units daily for 3 months

Primary outcomes1

Outcomes the sponsor listed as primary.

The Percent Change in Circulating Osteoprogenitor Cells as Assessed by Flow Cytometry in the Blood Before and After Treatment With Parathyroid Hormone (PTH) or Alendronate (ALN).
Time frame · up to 3 months

Secondary outcomes(2)

Difference in Bone Formation as Assessed by Bone Histomorphometry on Bone Biopsy Between Treatment Groups
Time frame · 3 months
Difference in Osteogenic Potential of Bone Marrow as Measure by Colony Forming Unit Osteoblast (CFU-Ob) Assays Between Treatment Groups
Time frame · 3 months

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 outcomeMean· up to 3 months

The Percent Change in Circulating Osteoprogenitor Cells as Assessed by Flow Cytometry in the Blood Before and After Treatment With Parathyroid Hormone (PTH) or Alendronate (ALN).

Group	Value (percent change in osteoprogenitor cells)	Spread
Teriparatide	0.0000242	0.0000283
Alendronate	0.0000104	0.0000231
Calcium and Vitamin D	-0.0000068	0.0000449

Secondary and other outcome results(2)

Secondary outcome· 3 months

Difference in Bone Formation as Assessed by Bone Histomorphometry on Bone Biopsy Between Treatment Groups

Group	Value
Teriparatide	not posted
Alendronate	not posted
Calcium and Vitamin D	not posted

Secondary outcome· 3 months

Difference in Osteogenic Potential of Bone Marrow as Measure by Colony Forming Unit Osteoblast (CFU-Ob) Assays Between Treatment Groups

Group	Value
Teriparatide	not posted
Alendronate	not posted
Calcium and Vitamin D	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Teriparatideteriparatide 20 mcg sq for 3 months Teriparatide: 20 mcg subq daily for 3 months	0 / 21	0 / 21	2 / 21
Alendronate70 mg po weekly for 3 months Alendronate: 70 mg weekly for 3 months	0 / 18	0 / 18	0 / 18
Calcium and Vitamin Dcalcium 630 mg vitamin D 500 units daily for 3 months calcium and vitamin D	0 / 16	0 / 16	1 / 16

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 50 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Post-menopausal women aged 50-80 years * T score \< -2.5 at lumbar spine, total hip or femoral neck on dual x-ray absorptiometry (DXA) OR T score \< -1.5 with a personal or family history of fracture Exclusion Criteria: * Previous use of bisphosphonates or Teriparatide; current estrogen therapy; any other osteoporosis therapy in the past 6 months * Metabolic bone disease other than osteoporosis * Body mass index (BMI) \< 18 * Weight \> 325 lbs * Current smoking or current alcohol use that exceeds 3 units of alcohol daily * Use of medications known to affect bone metabolism * Renal disease, history of kidney stones or hypercalciuria * Hypo- or hyperparathyroidism; hypo- or hypercalcemia * Serum vitamin D level \< 20 ng/dL * Refusal to adjust their dietary calcium to \<750mg (i.e. two servings per day of calcium rich food) * History of bone marrow or organ transplant * History of malignancy or radiation to the bone * History of esophageal stricture, dysmotility or severe reflux disease * Gastrointestinal malabsorption * Use of digoxin * Need for chronic anticoagulation therapy such as Coumadin, heparin or low molecular weight heparin or inability to discontinue anti-platelet medication * Bleeding diathesis; hemoglobin ≤ 12.5 g/dL (American Red Cross cut-off to donate blood) * International normalized ratio (INR) pro time \> 1.1 or activated partial thromboplastin time (APT) T ratio \> 1.2 * Platelets \< 150K/cu mm * Cellulitis at site of iliac crest * History of allergy to medications used in bone biopsy (demeclocycline, lidocaine) * Inability to understand and provide informed consent.

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