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Trial · Interventional

CompletedPhase 2Results postedRegistry data

The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa

NCTNCT00759772 (opens ClinicalTrials.gov in a new tab)Other id829
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
23 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Single masking
Countries
1 country

United States

Start
Sept 2008
Primary completion
22 Feb 2016
Completion
22 Feb 2016
First posted
25 Sept 2008 (estimated)
Last update posted
11 May 2017
Conditions
Anorexia Nervosa · Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082010201220142016
  1. Ph 2

    The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa

    NCT00759772

    Sept 2008 to 22 Feb 2016

Registry summary

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

Decreased bone strength is a common and serious medical problem present in many women with anorexia nervosa, or disordered eating. Women with decreased bone strength are more likely to suffer broken bones than women with normal bone strength. We are investigating whether a hormone that is naturally produced by the human body -- parathyroid hormone (PTH) -- can help strengthen the bones of women with anorexia nervosa.

Interventions

  • PlaceboDrug
  • TeriparatideDrug

Arms2

  • Active comparator

    Teriparatide

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change in Lumbar Spine Bone Mineral Density

    Time frame · Baseline and 6 months

    Registry description

    Percent increase or decrease in lumbar spine bone mineral density between baseline and 6 months (treatment period)

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· Baseline and 6 months

Percent Change in Lumbar Spine Bone Mineral Density

GroupValue (percentage of change)Spread
Teriparatide5.61.3
Placebo0.20.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
TeriparatideTeriparatide: Teriparatide 20 mcg sc daily for 6 months–2 / 1212 / 12
PlaceboPlacebo: Placebo 20 mcg sc daily for 6 months–3 / 119 / 12

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 30 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Anorexia Nervosa * Women, age 30-70 years * Osteoporosis or history of clinical fractures (spine, wrist, hip or ribs) Exclusion Criteria: * Diseases known to affect bone metabolism * Hyperparathyroidism * Medications known to affect bone metabolism in last 12 weeks (or bisphosphonate use in last 1 year) * Pregnant and/or breastfeeding * Diabetes mellitus * History of malignancy involving or affecting the bone, any active malignancy, and/or radiation therapy to the bone * Fractures of a bone other than a finger or toe in last 1 year

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