Growth Hormone DisorderANSWERNCT01009905

An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone)

An observational study of Growth Hormone Disorder and Pituitary Dwarfism, run by Novo Nordisk A/S 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

Search all trials

Trial summary

Who is it for?: Ages Up to 18 years
Conditions the study is for: Growth Hormone Disorder, Pituitary Dwarfism, Hypopituitarism
What is being tested?: somatropin
How many people: 22,960 participants
Where: 1 siteUnited States
Study dates: 24 Jun 2002to 30 Sep 2016
Phase: Observational
Are there results?: None posted in the registry

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 18 years
All sexes
No healthy volunteers
Child, Adult

Study population: Patients from both general and specialty practice settings, existing and new users of growth hormones, who have been deemed appropriate to receive Norditropin® as part of routine out-patient care by the prescribing physician.

Who may be able to join

Informed consent obtained
Children or adult patients treated with Norditropin® for an appropriate condition as prescribed by their physician

Who cannot join

Patients not being treated with Norditropin®
Patients who have discontinued treatment with Norditropin®
Known or suspected allergy to Norditropin® or related products
Contraindications for somatropin treatment consistent with the Prescribing Information for Norditropin®

Trial locations and contacts

1 site in 1 country.

United States1 site

Novo Nordisk Investigational Site
Plainsboro, New Jersey, 08536

Other trials in United States

About this study

Official title: Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth Hormone

This study is conducted in the United States of America (USA). The aim of this observational study is to collect data concerning the treatment outcomes and safety for children and adults who are prescribed Norditropin®. Specific objectives include: 1) developing models defining the relationship of Norditropin dose to changes in insulin-like growth factor (IGF-I) and treatment outcomes, accounting for independent factors such as age, gender and puberty and 2) determining the relative predictive values of peak growth hormone (GH) and IGF-I levels and other factors before treatment to clinical outcomes.

Conditions: Growth Hormone Disorder, Pituitary Dwarfism, Hypopituitarism
Being tested: somatropin
Medical subject headings: Dwarfism, Pituitary, Hypopituitarism

What participants receive

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

somatropinDrug
Safety and effectiveness data collection in connection with the use of Norditropin® (somatropin) in daily clinical practice

Study groups in NCT01009905
Study group	Role	What they receive
A		Not described Receives: Drug: somatropin

What is being measured

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

Change in height, measured as the height standard deviation score (HSDS), from the measurement made by the physician at study entry to the most recent clinic observation, end of GH treatment, de-registration, or change of clinic.
Measured: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Change in waist/hip circumference ratio for adult patients
Measured: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study

Secondary outcomes (5)

Short-term: Height, Height velocity, Height velocity standard deviation score (SDS), predicted adult height, height SDS for bone age, Proportion achieving height SDS > -2 at end of observational duration period
Measured: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Final Height (or Adult height), Final Height SDS, near-adult height, near-adult height SDS, Final Height - Target Height, Final height - predicted adult height, height age
Measured: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Final Height SDS - Target Height SDS, Final height SDS - predicted adult height SDS
Measured: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Proportion achieving HSDS of more than -2 at final height
Measured: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Weight, waist circumference, and hip circumference for adult patients
Measured: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study

Timeline

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

24 Jun 200230 Sep 2016

First posted9 Nov 2009 (estimated)
Study start24 Jun 2002
Primary completion30 Sep 2016
Study completion30 Sep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Growth Hormone DisorderStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 22,960 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01009905
Sponsor's protocol ID: HGH-2149
Other IDs: U1111-1111-1168
Acronym: ANSWER
Status last verified: Apr 2017
First submitted: 5 Nov 2009
Last updated: 12 Apr 2017
Results posted: No
Data monitoring committee: No

Publications

Ross JL, Lee PA, Gut R, Germak J. Attaining genetic height potential: Analysis of height outcomes from the ANSWER Program in children treated with growth hormone over 5 years. Growth Horm IGF Res. 2015 Dec;25(6):286-93. doi: 10.1016/j.ghir.2015.08.006. Epub 2015 Aug 22.
PubMed 26363846
Lee PA, Savendahl L, Oliver I, Tauber M, Blankenstein O, Ross J, Snajderova M, Rakov V, Pedersen BT, Christesen HT. Comparison of response to 2-years' growth hormone treatment in children with isolated growth hormone deficiency, born small for gestational age, idiopathic short stature, or multiple pituitary hormone deficiency: combined results from two large observational studies. Int J Pediatr Endocrinol. 2012 Jul 12;2012(1):22. doi: 10.1186/1687-9856-2012-22.
PubMed 22788856
Hoybye C, Savendahl L, Christesen HT, Lee P, Pedersen BT, Schlumpf M, Germak J, Ross J. The NordiNet(R) International Outcome Study and NovoNet(R) ANSWER Program(R): rationale, design, and methodology of two international pharmacoepidemiological registry-based studies monitoring long-term clinical and safety outcomes of growth hormone therapy (Norditropin(R)). Clin Epidemiol. 2013 Apr 26;5:119-27. doi: 10.2147/CLEP.S42602. Print 2013.
PubMed 23658497
Savendahl L, Blankenstein O, Oliver I, Christesen HT, Lee P, Pedersen BT, Rakov V, Ross J. Gender influences short-term growth hormone treatment response in children. Horm Res Paediatr. 2012;77(3):188-94. doi: 10.1159/000337570. Epub 2012 Apr 12.
PubMed 22508317
Rohrer TR, Kotnik P, Miller BS, Kelepouris N, Olsen AH, Pietropoli A, Polak M, Blair J. Better growth outcomes in GH-deficient children treated younger than 2 years of age. Endocr Connect. 2025 Sep 23;14(9):e250493. doi: 10.1530/EC-25-0493. Print 2025 Sep 1.
PubMed 40919719
Backeljauw P, Blair JC, Ferran JM, Kelepouris N, Miller BS, Pietropoli A, Polak M, Savendahl L, Verlinde F, Rohrer TR. Early GH Treatment Is Effective and Well Tolerated in Children With Turner Syndrome: NordiNet(R) IOS and Answer Program. J Clin Endocrinol Metab. 2023 Sep 18;108(10):2653-2665. doi: 10.1210/clinem/dgad159.
PubMed 36947589
Biller BMK, Hoybye C, Carroll P, Gordon MB, Birkegard AC, Kelepouris N, Nedjatian N, Weber MM. Pregnancy outcomes in women receiving growth hormone replacement therapy enrolled in the NordiNet(R) International Outcome Study (IOS) and the American Norditropin(R) Studies: Web-Enabled Research (ANSWER) Program. Pituitary. 2021 Aug;24(4):611-621. doi: 10.1007/s11102-021-01138-3. Epub 2021 Mar 12.
PubMed 33709288
Savendahl L, Polak M, Backeljauw P, Blair JC, Miller BS, Rohrer TR, Hokken-Koelega A, Pietropoli A, Kelepouris N, Ross J. Long-Term Safety of Growth Hormone Treatment in Childhood: Two Large Observational Studies: NordiNet IOS and ANSWER. J Clin Endocrinol Metab. 2021 May 13;106(6):1728-1741. doi: 10.1210/clinem/dgab080.
PubMed 33571362
Angulo M, Abuzzahab MJ, Pietropoli A, Ostrow V, Kelepouris N, Tauber M. Outcomes in children treated with growth hormone for Prader-Willi syndrome: data from the ANSWER Program(R) and NordiNet(R) International Outcome Study. Int J Pediatr Endocrinol. 2020 Nov 10;2020(1):20. doi: 10.1186/s13633-020-00090-6.
PubMed 33292530
Miller BS, Ross J, Ostrow V. Height outcomes in children with growth hormone deficiency and idiopathic short stature treated concomitantly with growth hormone and aromatase inhibitor therapy: data from the ANSWER program. Int J Pediatr Endocrinol. 2020;2020:19. doi: 10.1186/s13633-020-00089-z. Epub 2020 Oct 6.
PubMed 33042202
Weber MM, Gordon MB, Hoybye C, Jorgensen JOL, Puras G, Popovic-Brkic V, Molitch ME, Ostrow V, Holot N, Pietropoli A, Biller BMK. Growth hormone replacement in adults: Real-world data from two large studies in US and Europe. Growth Horm IGF Res. 2020 Feb;50:71-82. doi: 10.1016/j.ghir.2019.09.002. Epub 2019 Oct 26.
PubMed 31972476
Savendahl L, Polak M, Backeljauw P, Blair J, Miller BS, Rohrer TR, Pietropoli A, Ostrow V, Ross J. Treatment of Children With GH in the United States and Europe: Long-Term Follow-Up From NordiNet(R) IOS and ANSWER Program. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4730-4742. doi: 10.1210/jc.2019-00775.
PubMed 31305924
Rose SR, Reeves G, Gut R, Germak J. Attention-Deficit/Hyperactivity Disorder Medication Treatment Impact on Response to Growth Hormone Therapy: Results from the ANSWER Program, a Non-Interventional Study. J Pediatr. 2015 Dec;167(6):1389-96. doi: 10.1016/j.jpeds.2015.08.036. Epub 2015 Sep 26.
PubMed 26394822
Lee PA, Ross J, Germak JA, Gut R. Effect of 4 years of growth hormone therapy in children with Noonan syndrome in the American Norditropin Studies: Web-Enabled Research (ANSWER) Program(R) registry. Int J Pediatr Endocrinol. 2012 Jun 8;2012(1):15. doi: 10.1186/1687-9856-2012-15.
PubMed 22682146

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Growth Hormone Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth Hormone
ClinicalTrials.gov ID: NCT01009905
Acronym / sponsor ID: ANSWER / HGH-2149
Conditions: Growth Hormone Disorder, Pituitary Dwarfism, Hypopituitarism
Study type: Observational
Recruitment status: Completed
Enrolment: 22,960 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 24 Jun 2002 (actual)
Primary completion: 30 Sep 2016 (actual)
Study completion: 30 Sep 2016 (actual)
First posted: 9 Nov 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
A	–	Drug: somatropin

Who may qualify

Ages: Up to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Patients from both general and specialty practice settings, existing and new users of growth hormones, who have been deemed appropriate to receive Norditropin® as part of routine out-patient care by the prescribing physician.

Key inclusion criteria (2 listed)

Informed consent obtained
Children or adult patients treated with Norditropin® for an appropriate condition as prescribed by their physician

Key exclusion criteria (4 listed)

Patients not being treated with Norditropin®
Patients who have discontinued treatment with Norditropin®
Known or suspected allergy to Norditropin® or related products
Contraindications for somatropin treatment consistent with the Prescribing Information for Norditropin®

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
somatropinSafety and effectiveness data collection in connection with the use of Norditropin® (somatropin) in daily clinical practice	Drug	A

Primary outcome

Change in height, measured as the height standard deviation score (HSDS), from the measurement made by the physician at study entry to the most recent clinic observation, end of GH treatment, de-registration, or change of clinic.
Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Change in waist/hip circumference ratio for adult patients
Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study

5 secondary outcomes

Short-term: Height, Height velocity, Height velocity standard deviation score (SDS), predicted adult height, height SDS for bone age, Proportion achieving height SDS > -2 at end of observational duration period
Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Final Height (or Adult height), Final Height SDS, near-adult height, near-adult height SDS, Final Height - Target Height, Final height - predicted adult height, height age
Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Final Height SDS - Target Height SDS, Final height SDS - predicted adult height SDS
Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Proportion achieving HSDS of more than -2 at final height
Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Weight, waist circumference, and hip circumference for adult patients
Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
Results publication: PubMed 26363846Ross JL, Lee PA, Gut R, Germak J. Attaining genetic height potential: Analysis of height outcomes from the ANSWER Program in children treated with growth hormone over 5 years. Growth Horm IGF Res. 2015 Dec;25(6):286-93. doi: 10.1016/j.ghir.2015.08.006. Epub 2015 Aug 22.
Results publication: PubMed 22788856Lee PA, Savendahl L, Oliver I, Tauber M, Blankenstein O, Ross J, Snajderova M, Rakov V, Pedersen BT, Christesen HT. Comparison of response to 2-years' growth hormone treatment in children with isolated growth hormone deficiency, born small for gestational age, idiopathic short stature, or multiple pituitary hormone deficiency: combined results from two large observational studies. Int J Pediatr Endocrinol. 2012 Jul 12;2012(1):22. doi: 10.1186/1687-9856-2012-22.
Results publication: PubMed 23658497Hoybye C, Savendahl L, Christesen HT, Lee P, Pedersen BT, Schlumpf M, Germak J, Ross J. The NordiNet(R) International Outcome Study and NovoNet(R) ANSWER Program(R): rationale, design, and methodology of two international pharmacoepidemiological registry-based studies monitoring long-term clinical and safety outcomes of growth hormone therapy (Norditropin(R)). Clin Epidemiol. 2013 Apr 26;5:119-27. doi: 10.2147/CLEP.S42602. Print 2013.
Results publication: PubMed 22508317Savendahl L, Blankenstein O, Oliver I, Christesen HT, Lee P, Pedersen BT, Rakov V, Ross J. Gender influences short-term growth hormone treatment response in children. Horm Res Paediatr. 2012;77(3):188-94. doi: 10.1159/000337570. Epub 2012 Apr 12.
Derived from this study: PubMed 40919719Rohrer TR, Kotnik P, Miller BS, Kelepouris N, Olsen AH, Pietropoli A, Polak M, Blair J. Better growth outcomes in GH-deficient children treated younger than 2 years of age. Endocr Connect. 2025 Sep 23;14(9):e250493. doi: 10.1530/EC-25-0493. Print 2025 Sep 1.
Derived from this study: PubMed 36947589Backeljauw P, Blair JC, Ferran JM, Kelepouris N, Miller BS, Pietropoli A, Polak M, Savendahl L, Verlinde F, Rohrer TR. Early GH Treatment Is Effective and Well Tolerated in Children With Turner Syndrome: NordiNet(R) IOS and Answer Program. J Clin Endocrinol Metab. 2023 Sep 18;108(10):2653-2665. doi: 10.1210/clinem/dgad159.
Derived from this study: PubMed 33709288Biller BMK, Hoybye C, Carroll P, Gordon MB, Birkegard AC, Kelepouris N, Nedjatian N, Weber MM. Pregnancy outcomes in women receiving growth hormone replacement therapy enrolled in the NordiNet(R) International Outcome Study (IOS) and the American Norditropin(R) Studies: Web-Enabled Research (ANSWER) Program. Pituitary. 2021 Aug;24(4):611-621. doi: 10.1007/s11102-021-01138-3. Epub 2021 Mar 12.
Derived from this study: PubMed 33571362Savendahl L, Polak M, Backeljauw P, Blair JC, Miller BS, Rohrer TR, Hokken-Koelega A, Pietropoli A, Kelepouris N, Ross J. Long-Term Safety of Growth Hormone Treatment in Childhood: Two Large Observational Studies: NordiNet IOS and ANSWER. J Clin Endocrinol Metab. 2021 May 13;106(6):1728-1741. doi: 10.1210/clinem/dgab080.
Derived from this study: PubMed 33292530Angulo M, Abuzzahab MJ, Pietropoli A, Ostrow V, Kelepouris N, Tauber M. Outcomes in children treated with growth hormone for Prader-Willi syndrome: data from the ANSWER Program(R) and NordiNet(R) International Outcome Study. Int J Pediatr Endocrinol. 2020 Nov 10;2020(1):20. doi: 10.1186/s13633-020-00090-6.
Derived from this study: PubMed 33042202Miller BS, Ross J, Ostrow V. Height outcomes in children with growth hormone deficiency and idiopathic short stature treated concomitantly with growth hormone and aromatase inhibitor therapy: data from the ANSWER program. Int J Pediatr Endocrinol. 2020;2020:19. doi: 10.1186/s13633-020-00089-z. Epub 2020 Oct 6.
Derived from this study: PubMed 31972476Weber MM, Gordon MB, Hoybye C, Jorgensen JOL, Puras G, Popovic-Brkic V, Molitch ME, Ostrow V, Holot N, Pietropoli A, Biller BMK. Growth hormone replacement in adults: Real-world data from two large studies in US and Europe. Growth Horm IGF Res. 2020 Feb;50:71-82. doi: 10.1016/j.ghir.2019.09.002. Epub 2019 Oct 26.
Derived from this study: PubMed 31305924Savendahl L, Polak M, Backeljauw P, Blair J, Miller BS, Rohrer TR, Pietropoli A, Ostrow V, Ross J. Treatment of Children With GH in the United States and Europe: Long-Term Follow-Up From NordiNet(R) IOS and ANSWER Program. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4730-4742. doi: 10.1210/jc.2019-00775.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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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.

Global Clinical Registry (GCR, 1452), MD study director

Novo Nordisk A/S

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Growth Hormone Disorder and Pituitary Dwarfism, run by Novo Nordisk A/S 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 2 inclusion and 4 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 12 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 height, measured as the height standard deviation score (HSDS), from the measurement made by the physician at study entry to the most recent clinic observation, end of GH treatment, de-registration, or change of clinic. (time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.). The study lists 2 primary outcomes in all. 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 NCT01009905, which also lists 14 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 12 Apr 2017.